BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3150087 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08722
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL #(B)(4)) FOUND THAT THE SETSCREW WAS BACKED OUT TOO FAR. IT WAS C ROSS THREADED AND UNABLE TO TIGHTEN DOWN THE SETSCREW ONTO THE LEAD. ANALYSIS OF THE WRENCH ACCESSORY FOUND NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3889-28, LOT# J0349114V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID NEU_WRENCH_ACC. PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A POST-OP VISIT THE PATIENT¿S IMPEDANCES WERE ALL HIGH. THE PATIENT HAD A REVISION SURGERY AND AT THIS SURGERY IT WAS NOTED THAT THE ¿CLAMP¿ INSIDE THE DEVICE WAS NOT ADEQUATELY TIGHTENING DOWN ON THE LEAD. THE TORQUE WRENCH WAS ¿CLICKING¿ BUT THE ¿CLAMP¿ WAS NOT GETTING TIGHT ENOUGH. EACH TIME THE HEALTH CARE PROVIDER (HCP) TRIED, THE TORQUE WRENCH CLICKED BUT THE LEAD WAS NOT HELD IN PLACE. A NEW DEVICE WAS USED AND THE SITUATION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250830 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention