BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7925585 · Received October 2, 2018

    Report

    Report Number
    3004209178-2018-22015
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    June 1, 2018
    Report Date
    October 2, 2018
    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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THE PATIENT SAYS HER MOST RECENT IMPLANT HAD WORKED GREAT FOR HER AND WAS REPLACED BECAUSE THE BATTERY WAS LOW AND IT WAS INTERMITTENTLY WORKING TOWARD THE END OF BATTERY LIFE STARTING IN (B)(6) 2018; A MANUFACTURER¿S REPRESENTATIVE HAD CHECKED THE DEVICE. EVENTUALLY, THE BATTERY DIED. PATIENT THINKS IT WAS NORMAL BATTERY DEPLETION, BUT SHE ISN'T SURE. PATIENT SAYS SHE COULDN'T FEEL STIM ANYMORE, WHICH IS WHY SHE KNEW IT DIED. ON 2018-OCT-01 THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE HEALTHCARE PROFESSIONAL HAD INVITED HIM TO THE CLINIC TO CHECK THE BATTERY IN (B)(6) 2018, WHICH SHOWED IT HAD LIMITED (LESS THAN SIX MONTHS) SHELF LIFE WHEN THE DIAGNOSTIC CHECK WAS PERFORMED. THE REP WAS UNAWARE THERE WAS ANY DIAGNOSTIC CONCERN, SIMPLY A BATTERY CHECK THAT SHOWED NEAR END OF LIFE. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765863 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention