BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6257514 · Received January 17, 2017

    Report

    Report Number
    3004209178-2017-01036
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 26, 2016
    Report Date
    January 17, 2017
    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
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT PATIENT HAD ¿SLIP¿ LAST NIGHT BUT A VERY LITTLE ONE. IT WAS CLARIFIED THAT PATIENT MEANT SHE HAD A RETURN OF SYMPTOMS WHEN SHE SAID SLIP. PATIENT STATED HER HUSBAND INCREASED THE AMPLITUDE AND SHE WAS TOLD TO NOTIFY THE MANUFACTURER REPRESENTATIVE (REP) IF THEY MADE CHANGES, SO PATIENT WAS TRYING TO CONTACT THE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39806 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR