BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6753433 · Received July 31, 2017

    Report

    Report Number
    3004209178-2017-15865
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    May 1, 2017
    Report Date
    August 28, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. 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

    ADDITIONAL INFORMATION REPORTED. HEALTH CARE PROFESSIONAL REPORTED THE CAUSE OF THE LOSS OF STIMULATION WAS DETERMINED AND THAT THE PATIENT WAS ADJUSTING THE PROGRAM. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED BY CHANGING THE PROGRAM AND ADJUSTING THE INTENSITY OF THE STIMULATION. NO FURTHER INFORMATION REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPY. THE CALLER WAS CALLING TO DO A SYSTEM CHECK FOR A SUSPECTED LOW BATTERY. PATIENT SERVICES WALKED THE CALLER THROUGH INTERROGATING THE DEVICE, ICON SYNC, CHECKING IMPEDANCE AND REPROGRAMMING THE PATIENT. IMPEDANCES WERE TESTED AT: 1.0V AND 300 PW C0= 1559, C1= 783, C2= 771, C3=1610, 01=1610, 02=1610, 03=1849, 12=1559, 13=1559, 23=1559. THE PATIENT WAS TO TRY ADDITIONAL PROGRAMS TO DETERMINE THERAPEUTIC BENEFIT. THE PATIENT FELT STIMULATION ON ALL PROGRAMS IN THE RECTUM. PROGRAM 2 WAS NOTED TO BE UNCOMFORTABLE. THE PATIENT WAS USING PROGRAM 4 AT THE TIME OF THE CALL, BUT WAS GOING TO TRY PROGRAM 2 AND 3 WITH LOWER AMPLITUDES. THE PATIENT REPORTED NO SENSATION WHEN THEIR HUSBAND INCREASED STIMULATION 3 DAYS BEFORE THE REPORT, AND SUSPECTED THE BATTERY HAD DIED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535019 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR