BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7222443 · Received January 26, 2018

    Report

    Report Number
    3004209178-2018-01473
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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 WHO WAS IMPLANTED WITH AN INTERNAL NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT INDICATED SHE HAD THE DEVICE PERMANENTLY IMPLANTED AND SHE HAD BEEN HAVING TROUBLE WITH HER CONTROL LER. SHE STATED SHE WAS UNABLE TO TURN ON THE DEVICE AFTER GOING THROUGH AIRPORT SECURITY AND THAT THE BATTERIES HAVE DIED AND NEEDED TO BE REPLACED. NO SYMPTOMS REPORTED. NO FURTHER DEVICE COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    PATIENT LETTER WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT FAILED TO CHECK THE BATTERY LEVELS BEFORE ARRIVING AT THE AIRPORT. PATIENT HAD NOT TURNED THE DEVICE OFF CORRECTLY WHICH CAUSED PROBLEMS RESETTING THE DEVICE. PATIENT REPORTED SHE WAS THE KIND OF PERSON WHO WAS CHALLENGED WITH COMPUTER TYPE PROGRAMMER. PATIENT REPORTED THAT THE STEPS TAKEN TO RESOLVE THE ISSUE WERE THAT AFTER PATIENT PASSED THROUGH SECURITY, PATIENT CALLED THE MANUFACTURER HELPLINE AND PATIENT WAS WALKED THROUGH THE NEEDED HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65706 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR