BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ T SERIES

    MDR report key: 3152989 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01110
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN UNEXPECTED LONGEVITY. THE DEVICE PROJECTED LONGEVITY HAD BEEN 2.5 YEARS AND WITHIN APPROXIMATELY A YEAR THE DEVICE WAS AT REPLACEMENT STATUS. THE DEVICE IS STILL 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
    256141 DA+ T SERIES PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND T60A1U

    Patients

    Seq Age Sex Outcome Treatment
    1