BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2101723 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03424
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN TRIED TO TIGHTEN THE SETSCREW IN THE NEUROSTIMULATOR DOWN ON THE LEAD BUT IT REMAINED LOOSE (LEAD). SPECIFICALLY, THE LEAD WAS INSERTED ALL THE WAY INTO THE DEVICE UNTIL ALL 4 BLUE MARKINGS WERE SEEN AND THE TORQUE WRENCH TIGHTEN UNTIL A CLICK WAS HEARD, BUT THE LEAD WAS STILL LOOSE. THE LEAD WAS THEN RE-INSERTED AND THE SCREW AGAIN RETIGHTENED WITH NO SUCCESS. A NEW NEUROSTIMULATOR WAS THEN IMPLANTED WITH THE LEAD BEING SECURED IN PLACE WITH NO PROBLEMS. THE PATIENT WAS REPORTED AS DOING "GREAT" AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR LEAD: MODEL 3093, LOT # V210133| PROGRAMMER: MODEL 3037, LOT # NJD122468N| IMPLANTED:| EXPLANTED: