Potential for Device Reset
Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™
Original Date of Communication:
June 2018
View specific models that this applies to
Inactivated this document as part issue 82 - May 2020
Product
All models of Percepta and Percepta Quad CRT-P devices.
Advisory
Percepta and Percepta Quad CRT-P devices have the potential for a device reset to occur due to a timing interaction between the EffectivCRT™ Diagnostic and the Ventricular Safety Pacing feature (VSP). When an AP-VS interval measures 100-109ms during a short, nightly device check, a single reset is generated. This reset produces a non-programmable, wireless CareAlert™, but does not alter device therapy. If the device experiences more than five resets due to this timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. By design, a full reset automatically reverts device operation to RV-only pacing at VVI/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings.
No other Medtronic pacemaker, ICD, CRT-D or CRT-P device models are susceptible to this issue.
Status Update October 2019
A Software update, Application SW040 Version 8.1, was released in June 2018 as part of the original advisory notification. This software has been deployed onto Medtronic CareLink™ Model 2090 and Encore™ programmers to eliminate this issue. An in-clinic device interrogation will update the patient’s device automatically to prevent this timing interaction from generating a reset. No changes to programmed device functionality will occur as a result of this device update.
If the Patient Management guidance provided below is followed, no additional resets due to this timing interaction will occur.
Patient Management Recommendations
In consultation with the Independent Physician Quality Panel, Medtronic recommends the following actions:
- The updated Percepta CRT-P Application Software (SW040 Version 8.1) has been fully deployed worldwide onto Medtronic 2090 and Encore programmers.
- For a patient whose Percepta CRT-P device has experienced a Reset Alert or Observation:
Consider scheduling an in-clinic device interrogation as soon as possible for the patient’s device to receive the automatic update.
- For a patient whose Percepta CRT-P device has not experienced a Reset Alert or Observation:
At their next scheduled in-clinic device interrogation, the patient’s device will receive the automatic update.
How to verify a patient’s device has received the software update: |
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If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
PROGRAMMER USER SCREENS
Software Installation History Screen Image 1a |
Parameters Report- Device ID Information Image 2a |
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Image 1b |
Image 2b |
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