BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3006433 · Received March 15, 2013

    Report

    Report Number
    3007566237-2013-00798
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A "LUMBOSACRAL MRI." IT WAS NOTED THAT BOTH THE PATIENT'S PHYSICIAN AND THE MANUFACTURER REPRESENTATIVE RECOMMENDED "NOT TO PERFORM THE EXAM." IT WAS STATED THAT THE "DEVICE WAS SWITCHED OFF DURING THE EXAM" AND THAT "AFTER THE MRI, THE DEVICE WAS FOUND ON." IT WAS UNKNOWN AT THE TIME OF REPORT WHETHER THE PATIENT HAD USED HER PROGRAMMER TO TURN THE DEVICE ON. FOLLOWING THE MRI, THE PATIENT REPORTED "A DIFFERENT PERCEPTION OF THE PARESTHESIA." THE PATIENT NOTED THEY WERE FEELING "PARESTHESIA" "AT THE LEVEL OF HER THIGH AND LATERAL PELVIS." IMPEDANCE TESTING REVEALED THAT EVERYTHING "SEEMED TO BE OK." X-RAY RESULTS INDICATED THAT THE LEAD "SEEMED TO BE DEEPER BY A FEW CM" WHEN COMPARED TO A PREVIOUS X-RAY. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109879 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1