BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5066959 · Received September 10, 2015

    Report

    Report Number
    3004209178-2015-17649
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3093-33, LOT # V020255, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THERE WAS A LOSS OF THERAPY AND A POPPING SENSATION ON A RANDOM BASIS. SHE ALSO WAS NOT FEELING HER DEVICE, EVEN AFTER GREATLY INCREASING THE AMPLITUDE. ON AN UNKNOWN DATE, THE PATIENT NOTICED SHE WAS NO LONGER GETTING SYMPTOM RELIEF. AN IMPEDANCE CHECK WAS DONE AND ALL ELECTRODE COMBINATIONS WERE ABOVE 4000 OHMS ASIDE FROM C<(>&<)>0, C<(>&<)>2, 0 <(>&<)>1, AND 1<(>&<)>2. THE SETTINGS WERE REPROGRAMMED AND THE PATIENT WAS INSTRUCTED TO TRY USING THE NEW PROGRAMS THAT WERE BASED AROUND THE IMPEDANCE FINDINGS. THE PATIENT HAD FOLLOW-UP NEXT WEEK WITH THE HEALTH CARE PROFESSIONAL (HCP). THE HCP WAS AWARE OF THE CURRENT ISSUES AND WAS ALSO PLANNING TO X-RAY HER LEAD. THE PATIENT HAD RECENT BATTERY REPLACEMENT DUE TO END-OF-LIFE OF PRIOR BATTERY. SHE WAS FEELING STIM POST-OPERATIVELY. SURGICAL INTERVENTION DID NOT OCCUR AND IT WAS UNKNOWN IF IT WAS PLANNED. AFTER FOLLOW-UP WITH THE REP, THERE WAS NO FURTHER INFORMATION. THE PATIENT WAS GOING TO FOLLOW-UP WITH THEIR HCP BUT THE REP HAD NOT HEARD ANYTHING FURTHER. THE INDICATION-FOR-USE (IFU) WAS URINARY DYSFUNCTION/SACRAL NERVE STIM. NO OUTCOME OR INTERVENTION WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600028 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR