BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2081442 · Received April 22, 2011

    Report

    Report Number
    3004209178-2011-03046
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING STAGE II OF THE INITIAL IMPLANT OF THE INS, THE LEAD EXTENSION WOULD NOT FIT INTO THE BACK HOLE OF THE INS. THE SET SCREW WAS RELEASED, BUT IT WAS STILL NOT POSSIBLE TO PUT THE EXTENSION INTO THE INS. THE DEVICE WAS NOT USED IN THE PT. ANOTHER INS WAS IMPLANTED INSTEAD. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN009074V| LEAD: MODEL 3387S, LOT# V539902| LEAD: MODEL 3387S, LOT# V585792| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN015263V| EXPLANTED: