BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ENRHYTHM

    MDR report key: 2145750 · Received June 24, 2011

    Report

    Report Number
    MW5021157
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A MEDTRONIC ENRHYTHM (B)(4) PMK. IMPLANTED 2005. MEDTRONIC HAD ISSUED AN ADVISORY IN (B)(6) 2011, RE: EARLY BATTERY DEPLETION OF THIS DEVICE. NEW SOFTWARE WAS APPARENTLY LOADED INTO THE MEDTRONIC PROGRAMMERS, IN THE PHYSICIANS OFFICE, AS WELL AS ELSE WHERE. THIS PROGRAMMING UPGRADE THEN RESET NEW BATTERY LONGEVITY CRITERIA, AND HAD THE POTENTIAL TO CAUSE RAPID PACEMAKER BATTERY DEPLETION. MEDTRONIC REPORTS THIS OCCURS 1% OF THE TIME. THIS PATIENT EXPERIENCED RAPID BATTERY DEPLETION, AND SHE WAS PACEMAKER DEPENDENT. SHE SUFFERED SYMPTOMS OF SEVERE SOB AND FATIGUE FOR 3 MONTHS, AS PMK REVERTED TO BACKUP MODE. SHE HAD EXTENSIVE WORK UP FOR THESE SYMPTOMS. PHYSICIANS AND HOSPITALS WERE NOT NOTIFIED OF THIS POSSIBILITY. IT APPEARS THAT MEDTRONIC DOES NOT HAVE ANY INTENSIFIED FOLLOW UP RECOMMENDATIONS FOR THESE ENRHYTHM DEVICES, THAT COULD EXPERIENCE RAPID BATTERY DEPLETION. MWH REPORTS THAT THEY HAVE 6 ENRHYTHM PATIENTS (OUT OF 149 IMWH IMPLANTED ENRHYTHM PATIENTS) THAT HAVE EXPERIENCED THIS. A MEDTRONIC FOLLOW UP RECOMMENDATION WOULD BE DESIRABLE. DATES OF USE: (B)(6) 2005 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ENRHYTHM PACEMAKER GENERATOR NVZ MEDTRONIC P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization