BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8701130 · Received June 14, 2019

    Report

    Report Number
    3004209178-2019-11656
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 14, 2019
    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
    OK, US
    Reporter Occupation
    003

    Narratives

    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 THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS AROUND MEDICAL EQUIPMENT/ENVIRONMENT ON (B)(6) 2019 AND A POWER-ON-RESET (POR) WAS SEEN AFTER THAT ON THE SAME DAY. NO SYMPTOMS WERE REPORTED IN THE EVENT. THE PATIENT STATED ON (B)(6) 2019 THAT THEY DID NOT WANT TO WAIT ALL WEEKEND FOR SOMEONE TO CLEAR THE POR MESSAGE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2019 FROM THE MANUFACTURER¿S REPRESENTATIVE REPORTED THAT THE PATIENT WAS DEFIBRILLATED AND GOT THE CALL YOUR DOCTOR/POR MESSAGE. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492287 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR