BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5698879 · Received June 3, 2016

    Report

    Report Number
    3004209178-2016-10866
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    January 31, 2016
    Report Date
    June 3, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V850492, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.

    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 PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THERE WAS A LOSS OR CHANGE OF THERAPY. SHE STARTED HAVING BREAK THROUGH FECAL INCONTINENCE AT THE END OF JANUARY OR BEGINNING OF FEBRUARY. SHE SAW THE DOCTOR AND HE CHECKED HER DEVICE BUT SAID HE DID NOT WORK WITH FECAL INCONTINENCE SO HE WOULD DO ANYTHING ELSE. WHEN HE CHECKED THE DEVICE HE TOLD HER ONE OF THE WIRES WAS BROKEN OR PULLED OUT OR WHATEVER. AFTER THE APPOINTMENT SHE INCREASED STIMULATION AND HER FECAL INCONTINENCE HAD IMPROVED SO SHE THOUGHT SHE MIGHT HAVE JUST HAD A VIRUS. WHEN THE DOCTOR CHECKED THE DEVICE HE TURNED HER STIMULATION UP HIGH AND SHE JUMPED OFF THE TABLE AND FELT A SHOCK; THIS OCCURRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352480 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR