Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardi

FDA device recall Z-2415-2018 · posted 2018-07-10 · Terminated

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Reason for recall

Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).

Action taken

On 21-Jun-2018, Medtronic began notifying US physicians and health care professionals of this issue and provided Patient Management recommendations to ensure patient safety. A Software Update to SW040 Version 8.1 will be deployed to all Medtronic 2090 and Encore clinic and hospital programmers via the Software Distribution Network or USB. Field Representatives with customers who have Percepta CRT-P patients will be sent a USB device loaded with the updated software. In consultation with an Independent Physician Quality Panel, Medtronic recommends the following actions for physicians following patients: - Contact your local Medtronic Representative and schedule installation of the updated Percepta CRT-P Application Software (SW040 Version 8.1) onto Medtronic 2090 and Encore clinic and hospital 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 patients 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 patients device will receive the automatic update. Please complete the enclosed Clinician Confirmation Certificate and return via email to RS.CFQFCA@medtronic.com. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Root cause

Device Design

Status

Terminated

Product code

NKE

Quantity affected

3560 units

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2018-06-21

Date posted

2018-07-10

Date terminated

2020-08-19

Location

Mounds View, MN