BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2770796 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08839
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V855059, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPEDANCES WERE CHECKED AND NO MALFUNCTIONS WERE SEEN. THE ISSUE WAS NOT RESOLVED WITH REPROGRAMMING AND IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STIMULATION IN THE LEG AND IN SOME CASES LEG ROTATION ON ALL FOUR OF THE ELECTRODES. THE PATIENT WAS NOT SEEING SYMPTOM RELIEF FROM THE IMPLANT AND WAS DECIDING ON WHAT HER NEXT STEP WOULD BE. IT WAS NOTED THAT THE PATIENT THOUGHT THE LEADS WERE PLACED INCORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE STIMULATOR WAS WORKING AT ABOUT 70%, BUT PATIENT HAD NOT "FELT STIMULATION CORRECTLY" FOR ABOUT A MONTH. THE PATIENT WAS ON PROGRAM 4 AT 1.9V. IF SHE INCREASED THE AMPLITUDE IT CAUSED STIMULATION IN HER LEG AND HER FOOT TURNED IN. THE PATIENT TRIED PROGRAMS 1 AND 3, BUT STIMULATION DID NOT IMPROVE. THE PATIENT RECENTLY HAD A COLONOSCOPY AND WALKED THROUGH AIRPORT SECURITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1