BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2954605 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00464
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 15, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA WERE COLLECTED FROM THE DEVICE, SUBMITTED TO THE MANUFACTURER, AND ANALYZED. NO ANOMALIES WERE OBSERVED. THE DEVICE TESTING ISSUES WERE POSSIBLY RELATED TO A BIT FLIP MEMORY ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP VISIT, IT WAS NOT POSSIBLE TO PERFORM A SENSING AND THRESHOLD TEST ON THE DEVICE INDICATIVE OF A POSSIBLE FLIPPED BIT ERROR IN THE RAMWARE. A MANUAL GUIDED RESET WAS PERFORMED AND THE DEVICE RETURNED TO NORMAL FUNCTION AND 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
    57937 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND T70A1U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention