Reveal LINQ with TruRhythm - Brady & Pause Detections Disabled Following Electrical Reset

Reveal LINQ with TruRhythm Insertable Cardiac Monitoring Systems
Original Date of Communication: June 2021

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STATUS UPDATE - NOVEMBER 2023

This advisory is being addressed via a software update. Medtronic CareLink (2090) and Encore (29901) Programmer software, SW026 version 8.3, is available to correct a low rate of occurrence issue with Reveal LINQ ICMs (0.049%) where Brady and Pause detections are disabled following a partial electrical reset.

Reveal LINQ ICMs that are interrogated in-office with an updated 2090 or Encore programmer are no longer susceptible to this issue. This corrective fix to the device cannot be delivered with the Reveal LINQ™ Mobile Manager (LMM). Until the update is installed, future partial electrical resets may disable Brady and/or Pause detections as described in the June 2021 communication.

Note: The immediate availability of the software release is specific to countries that follow FDA approval, or that do not require software to be regulated. Release timing may differ for other geographies including those that require CE Mark approval. Check with your local Medtronic representative to determine if the software update is available in your region.

Please work with your local Medtronic Representative to update all 2090 and Encore device programmers. In addition, Medtronic requests you follow the below patient management recommendations:

Patient Management Recommendations:

• Reveal LINQ ICMs with a confirmed partial electrical reset will receive the corrective fix for this issue immediately by the device clinician completing the following steps:
  1. Interrogate the ICM with an updated 2090 or Encore programmer (software application SW026 version 8.3). The corrective fix is automatically installed during initial interrogation. To confirm an ICM has successfully received the update, refer to Appendix A.
  2. Per the Instructions for Use (IFU), following any electrical reset, verify ICM parameters are set appropriately for the patient and reprogram if necessary.

• For Reveal LINQ ICMs that have not experienced a partial electrical reset, an update will occur during the next in-clinic visit in which an updated Model 2090 or Encore programmer installed with software application SW026 version 8.3 (or higher) is used to interrogate the ICM. Partial electrical resets will disable Brady and/or Pause detections as described in the June 2021 communication until the update is installed on to the patient’s ICM.
  • For patients who are actively followed on CareLink, continue routine monitoring for CareAlerts and verify notification settings for electrical resets.
  • Per the IFU, notify your Medtronic representative if an electrical reset occurs. If a partial electrical reset is confirmed, the patient’s ICM will require reprogramming.
  • During the programmer session, the corrective fix will be installed automatically.

ORIGINAL COMMUNICATION - JUNE 2021

This notice is to inform you that Reveal LINQ with TruRhythm ICMs that undergo a partial electrical reset appear to be programmed “ON,” but are no longer able to detect and report Brady and Pause events to clinicians. Medtronic estimates that 0.049% of Reveal LINQ with TruRhythm ICMs have experienced a partial electrical reset resulting in the inability to detect Brady and Pause events. While there is a potential for underreporting due to lack of awareness that an electrical reset has occurred, there have been zero (0) serious or permanent harms or deaths reported as a result of this issue. After a partial electrical reset, these Brady and Pause episode types will not be reported to the clinician.

• Currently implanted/distributed Reveal LINQ with TruRhythm ICMs will receive a future software update to correct this issue delivered via the Model 2090 and Encore™ programmers. The corrective fix is anticipated to be available late calendar year 2021 (U.S.). Availability of the software will be communicated once Medtronic has obtained the necessary regulatory approvals.

• There will be an update for future manufactured Reveal LINQ with TruRhythm ICMs, which is anticipated to be available in the U.S. October 2021. Medtronic will inform physicians once this manufacturing update is implemented into newly manufactured Reveal LINQ with TruRhythm ICMs.

ISSUE DESCRIPTION

Medtronic has identified that Reveal LINQ with TruRhythm ICMs that undergo a partial electrical reset appear to be programmed “ON,” but are no longer able to detect and report Brady and Pause events. A partial electrical reset is normal behavior that can occur when the device detects a possible issue with the device software. However, an error in the partial electrical reset implementation is causing this unintended behavior.

All Reveal LINQ with TruRhythm ICMs currently in distribution are susceptible to this issue. Through 10 May 2021, Medtronic has received 87 complaints related to an electrical reset. The projected rate of a Reveal LINQ with TruRhythm ICM experiencing a partial electrical reset that results in the inability to detect Brady and Pause events is 0.056% at 36 months. Complaint data suggests the majority of electrical resets were associated with Electromagnetic Interference (EMI) due to cardioversion or electrocautery. Potential harms include those associated with the risk of a delayed medical intervention or missed diagnosis for Brady and Pause events, and an explant procedure.

If a partial electrical reset occurs, CareLink™, Model 2090 and Encore programmer software and Reveal LINQ™ Mobile Manager (LMM) will continue to indicate that detection parameters are “ON;” however, Brady and Pause events will not be automatically collected. The Patient Assistant (Patient Activator) will continue to function to manually trigger ECG collection, store the tracing, and mark symptoms.

Tachy and AT/AF detections are not affected by a partial electrical reset.

HOSPITAL RISK MANAGER ACTIONS (U.S. CUSTOMERS ONLY)

1. Please share this notification with the Cardiology and cardiac monitoring departments, Pacemaker/Device Clinic leadership, and physicians who implant or manage patients with LINQ II insertable cardiac monitors (ICMs).
2. Complete the enclosed Confirmation Form and email to RS.CFQFCA@medtronic.com

PATIENT MANAGEMENT RECOMMENDATIONS

If an electrical reset has never occurred, all detection criteria are being monitored and recorded as programmed. Continue with normal follow-up per local clinic protocols for these patients.

Identifying if an electrical reset has occurred:

For patients who are actively followed on CareLink in the U.S: During our investigation of this issue, we identified patients whose device showed evidence of a partial electrical reset as of 10 May 2021. For those clinicians with identified patients, a supplemental letter was provided. If you have not received a supplemental letter, then none of your patients who are actively transmitting on CareLink were identified as having a recorded electrical reset event during our investigation.

All patients, including those on CareLink, should be carefully monitored for reports of an electrical reset condition. Follow instructions below.

• During in person or remote follow-up: If a device experiences an electrical reset, clinicians will be informed via programmer pop-up or CareLink display message. Actively monitor for these notifications at each patient follow-up, and contact Medtronic Technical Services should you receive an alert. Note: Once cleared, electrical reset notifications are no longer accessible.

• Retroactively: Review the Brady lifetime episode counter from the most recent session report (CareLink or in-office). If a report is not available, consider scheduling a follow-up for each patient being monitored for Brady or Pause events. Review the Brady lifetime episode counter:
  • If the lifetime count for Brady is non-zero, a partial electrical reset has not occurred.
  • If the lifetime count for Brady is zero, and the Brady detection parameter indicates it is “ON,” a partial electrical reset may have occurred. Contact Medtronic Technical Services for assistance by emailing RS.LINQElectricalResetFCA@medtronic.com (U.S.) OR calling 1-800-929-4043 (U.S.).

Patients with a confirmed partial electrical reset:

• Medtronic medical staff, in consultation with our Independent Physician Quality Panel, recommends against device replacement for patients being monitoring for Tachy or AT/AF; continue normal patient follow-up.

• When monitoring for Brady or Pause events, it is important to note that the Patient Assistant (Patient Activator) will continue to manually mark symptoms even after a partial electrical reset. Patient-activated recordings are not impacted by this issue. If patients require monitoring for Brady and/or Pause events, and it is not acceptable to wait for the software update to become available (see details below), consider device replacement. Recognize that exposure to EMI could introduce this issue for new device implants that occur before the manufacturing update is implemented anticipated in the U.S. in October 2021.

• As a reminder, per the Reveal LINQ with TruRhythm ICM’s Instructions for Use, contact Medtronic anytime an electrical reset occurs.

FUTURE SOFTWARE UPDATE AVAILABILITY

Medtronic is developing a programmer-delivered software update to correct this issue for Reveal LINQ with TruRhythm ICMs currently implanted or in distribution. Anticipated availability in the U.S. is late calendar year 2021; Medtronic representatives will inform you of the availability and work with you to install the software onto clinic and hospital 2090 and Encore programmers. LMM application software will be unable to deliver the software update for this issue. In order for patients with Reveal LINQ with TruRhythm ICMs to receive the update, the device will need to be interrogated with an updated 2090 or Encore programmer.

APPENDIX A

Reveal LINQ™ with TruRhythm™ Insertable Cardiac Monitoring Systems

Brady & Pause Detections Disabled Following Partial Electrical Reset

Software Update Available

How do I update my Model 2090 and Encore programmers with the Reveal LINQ with TruRhythm software described in the November 2021 communication)?

Software update SW026 version 8.3 can be installed onto all Model 2090 or Encore programmers through either the Medtronic Software Distribution Network (SDN) or via a USB. Medtronic representatives will work with you to install the software.

How do I confirm if a Model 2090 or Encore programmer has already been installed with the updated software (SW026 v8.3)?

From the Find Patient screen on the programmer, Tap the Programmer Icon, select “Software,” and scroll through the list of installed applications to find Reveal LINQ Software Version 8.3.

How do I confirm if a patient’s Reveal LINQ ICM has received the software update?

Clinicians can confirm if a patient’s ICM has received the software update by verifying the Device Configuration ID via a 2090 or Encore programmer (LMM will not display the Configuration ID). To locate the Device Configuration ID, enter a follow-up session and Print the Parameters Report. All Reveal LINQ ICMs that have received the software update will have their Configuration ID ending in a “1” (e.g. X-X-X-1).

NOTE: The Reveal LINQ Device Configuration ID can be viewed on CareLink beginning January 2022 after a manual transmission is completed by the patient.

Specific Models This Applies To