BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4102715 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17393
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0LLSL, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED THAT THE SETSCREW WAS BACKED OUT TOO FAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN HAD A DIFFICULT TIME TIGHTENING THE SCREW ON THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WOULD NOT TORQUE DOWN IN THE NORMAL FASHION. WHEN AN IMPEDANCE CHECK WAS PERFORMED, OVER 75 PERCENT OF THE CONFIGURATIONS HAD HIGH IMPEDANCE AND VALUES GREATER THAN 4000 OHMS. THE PHYSICIAN UNSCREWED THE INS FROM THE LEAD, CLEANED OFF THE LEAD, AND REINSERTED IT INTO THE INS. THE INS WAS PLACED INTO THE POCKET AND IMPEDANCES WERE RETESTED. THIS HAD THE SAME RESULTS AND WAS ATTEMPTED MULTIPLE TIMES. STIMULATION WAS NOT FELT INTRA-OPERATIVELY AS THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PHYSICIAN DIDN¿T FEEL COMFORTABLE WITH THE IMPEDANCES AND THE PERFORMANCE OF THE SCREW NOT TIGHTENING AND LOOSENING CORRECTLY. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE DEVICE WAS NOT IMPLANTED AND A NEW INS WAS OPENED AND USED INSTEAD. THE PRODUCT ISSUE WAS RESOLVED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584495 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR