Advisories
Potential for Device Reset

Potential for Device Reset

Percepta™ CRT-P MRI SureScan™ and Percepta™ Quad CRT-P MRI SureScan™
Original Date of Advisory: June 2018

View specific models that this applies to

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 April 2019

As of April 2019, a Software update, Application SW040 Version 8.1, has been deployed onto all CareLink™ Model 2090 and Encore™ programmers to eliminate this issue. Once installed on a programmer, 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:

  • Ensure the programmer has been updated to Percepta Application Software “Version 8.1” by viewing the software installation history under the Programmer Icon; Refer to Image 1a and 1b.
  • Interrogate the patient’s device; Print the Parameters Report –Verify the Device ID listed at the bottom of the printout displays “Device Configuration ID: 1-0-0”or "Device Configuration ID: 1-1-0; Refer to Images 2a and 2b.
  • If the Parameters Report does not display the new Device ID number, verify that the correct software application has already been installed (SW040 Version 8.1). 
  • If the programmer has not been updated, install Software Application SW040 Version 8.1 and re-interrogate the patient’s device.  
  • If the programmer has been updated and the Device Configuration ID is not 1-0-0 or1-1-0, the patient’s device was unable to successfully receive the update. Contact Medtronic Technical Services for additional instructions.

 

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

Image 1b

Image 2b



Specific Models This Applies To

www.medtronic.com/productperformance 651050