BEUDAMED
    FDA Recall Terminated

    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    Recall: Z-2415-2018 · Initiated June 21, 2018

    Recall

    Recall Number
    Z-2415-2018
    Event Number
    80433
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    NKE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 21, 2018
    Posted
    July 10, 2018
    Terminated
    August 19, 2020
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

    Reason

    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

    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 [email protected]. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    3560 units