BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5682630 · Received May 26, 2016

    Report

    Report Number
    3004209178-2016-10425
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 26, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V012404, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THE HOSPITAL HAD A DEFECTIVE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS IN SURGERY ON (B)(6) 2016 FOR NORMAL BATTERY DEPLETION. A NEW LEAD WAS CONNECTED TO A NEW INS AND THE SETSCREW WAS TIGHTENED. THEY HEARD CLICKING OF THE TORQUE WRENCH, BUT THE LEAD PULLED OUT OF THE HEADER. THE SETSCREW WOULD NOT SEAT ONTO THE LEAD. ANOTHER NEW INS WAS IMPLANTED TO RESOLVE THE ISSUE. THERE WERE NO ASSOCIATED SYMPTOMS. THE PATIENT'S INDICATION(S) FOR USE WERE URINARY DYSFUNCTION AND SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336673 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR