BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ T SERIES DR

    MDR report key: 2811980 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02393
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY OF THE DEVICE HAS HAD "DRAMATIC BATTERY DEPLETION" SINCE THE VISIT NINE MONTHS EARLIER. 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
    1 DA+ T SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. T70A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other