BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPTA CRTP

    MDR report key: 7558494 · Received May 31, 2018

    Report

    Report Number
    3004209178-2018-12302
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 3, 2018
    Report Date
    June 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NKE
    UDI-DI
    00643169735637
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A SOFTWARE ERROR. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT THE ATRIAL AND VENTRICULAR RATE HISTOGRAM DATA WERE MISSING/INVALID. MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RESET OCCURRED ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) THAT CLEARED THE RATE AND PERCENTAGE PACING DATA. FOLLOW UP YIELDED NO INFORMATION AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400004 PERCEPTA CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION NKE MEDTRONIC PUERTO RICO OPERATIONS CO. W1TR01 00643169735637

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR