BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 2955369 · Received February 11, 2013

    Report

    Report Number
    9614453-2013-00288
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    July 28, 2011
    Report Date
    December 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PARTIAL RESET OF DATA COLLECTION. THE DEVICE RESTORED TO THE PROGRAMMED SETTINGS AUTOMATICALLY 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
    57942 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C20A2U

    Patients

    Seq Age Sex Outcome Treatment
    1