BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 10868071 · Received November 19, 2020

    Report

    Report Number
    3004209178-2020-20278
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    August 15, 2020
    Report Date
    November 19, 2020
    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
    MN, 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 HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT SINCE AUGUST, THE PATIENT IS FEELING "ZAP", "ZING" AT POCKET SITE, THAT IT'S CAUSING THE PATIENT PAIN. PATIENT HAS TURNED THERAPY OFF AND THE PAIN GOES AWAY, BUT THE PATIENT HAS RETURN OF SYMPTOMS. IMPEDANCE CHECK SHOWS: C0 1063 OHMS, C1 1063, C2 1063, C3 1063, 01 1135, 02 1261, 03 1419, 12 1098, 13 1174, 23 1098 OHMS. TECHNICAL SERVICES REVIEWED WITH CALLER THAT GIVEN PATIENT IS FEELING SENSATION AT POCKET SITE ONLY WHEN THERAPY IS ON, IT'S LIKELY THAT PATIENT HAS A FLUID SHORT AT THE POCKET. THE PATIENT IS NOT PROGRAMMED USING THE CASE, 0-3+. THERE IS NO FALL/ACCIDENT OR TRAUMA REPORTED. THE PATIENT IS AN ATHLETE. THEY CAN'T TOLERATE SENSATION EVEN AT 0.3 VOLTS. SHE GENERALLY NEEDS TO BE AROUND 2 VOLTS TO HAVE THERAPEUTIC BENEFIT. TECHNICAL SERVICES TOLD NURSE THAT GI VEN THE PATIENT CAN'T TOLERATE STIM ON EVEN AT A LOW LEVEL, REVISION IS LIKELY NEEDED TO ADDRESS STIM AT POCKET ISSUE. THE NURSE REPORTED THAT THE PATIENT'S THERAPY HASN'T BEEN AS GOOD SINCE LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335002 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR