BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2963749 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02704
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA03KNE, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A BURNING SENSATION. IT WAS STATED THAT THE THERAPEUTIC EFFECT DURING THE LAST TWO WEEKS OF THE PATIENT'S TRIAL WERE "AMAZING," BUT SINCE BEING IMPLANTED SHE "DIDN'T FEEL STIMULATION AT ALL AND IT DID NOT CHANGE ANY OF HER SYMPTOMS." IT WAS STATED THAT SINCE THE TRIAL, THE PATIENT HAD "NO EFFECT." IT WAS NOTED THAT SHE HAS SINCE BEEN REPROGRAMMED SO THAT ALL FOUR PROGRAMS "STIMULATE HER PELVIC AREA." THE PATIENT REPORTEDLY EXPERIENCED A "BURNING" SENSATION IN THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET AREA AFTER INCREASING HER STIMULATION. IT WAS NOTED THAT THE PATIENT'S PHYSICIAN "WANTED TO GET BACK IN AND MOVE THE LEAD FROM THE RIGHT TO THE LEFT." THE PATIENT WAS REDIRECTED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68073 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1