BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3913371 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12520
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3093-28, LOT# VA011WG, PRODUCT TYPE LEAD. PRODUCT ID NEU_SET_SCREW, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTHCARE PROVIDER WAS TRYING TO TIGHTEN A SET SCREW OF AN IMPLANTABLE NEUROSTIMULATOR (INS) ONTO A LEAD AND WHEN THE LEAD WAS PUT IN AND SCREWED DOWN, THE LEAD WAS STILL LOOSE. THE LEAD WAS RE-INSERTED 4-5 TIMES AND A MANUFACTURER REPRESENTATIVE WAS UNSURE IF THE SET SCREW MAY HAVE BEEN BACKED OUT TOO FAR. A DIFFERENT SCREWDRIVER WAS TRIED AND THE SAME THING HAPPENED WHERE THE LEAD WOULD EASILY SLIP OUT OF THE PORT. IT WAS LATER REPORTED THAT ANOTHER INS WAS OPENED AND IT WORKED FINE. THE PATIENT WAS DOING WELL AND RECEIVING THERAPY IN THE APPROPRIATE TARGETED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389649 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR