BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1913539 · Received November 12, 2010

    Report

    Report Number
    9614453-2010-09398
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEURO STIMULATOR (INS) WAS IMPLANTED IN THE PT 10 WEEKS PRIOR TO THE REPORT AND READ 2.8 VOLTS, AND LATER SHOWED AN EOS (END OF SERVICE) MESSAGE AND THE BATTERY VOLTAGE WAS 2.82 VOLTS. THE PT WAS SENT HOME AND INS WAS TO BE MONITORED. NO ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC EUROPE SARL 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1