BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8966824 · Received September 5, 2019

    Report

    Report Number
    3004209178-2019-17064
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    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

    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 (CON) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). THE PATIENT REPORTED THAT THE NEW ONE DOESN¿T WORK EITHER AND CLARIFIED THAT HER NEW STIM PUT IN ON (B)(6) 2019 HASN¿T HELPED HER SYMPTOMS YET, AND THAT "I¿M GOING THROUGH PADS LIKE I DID BEFORE AND ITS NOT HELPING A BIT." PATIENT SERVICES HELPED THE PATIENT USE HER CONTROLLER, AND SHE SAID STIM WAS ON, ON PROGRAM 3 AT 2.6 AND SHE WAS NOT FEELING STIMULATION. THE PATIENT STATED "YESTERDAY I FELT IT ON THE TOE ON MY RIGHT FOOT." THE PATIENT STATED SHE SAID THIS TO A MANUFACTURER REPRESENTATIVE (REP), AND THEY WERE AT THE GAS STATION "SO WE DIDN¿T TALK VERY LONG". THE PATIENT WAS GOING TO INCREASED TO 2.7 AND WAS GOING TO TRY THIS SETTING. PATIENT SERVICES REVIEWED HOW THE THERAPY WORKS, AND TO FOLLOW UP WITH THE HCP WITH ANY QUESTIONS. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758266 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR