BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2100267 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03525
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT PATIENT SUFFERED A LACK OF THERAPEUTIC EFFECT FOLLOWING AN MRI SCAN. PATIENT REPORTED SHE WAS HALFWAY THROUGH THE SCAN AND FELT A BURNING SENSATION, AT WHICH POINT, THE SCAN WAS STOPPED. SHE SAID IT "FELT LIKE FIRE." PATIENT LOST THERAPEUTIC EFFECT AFTER THE MRI AND SHE CAN'T FEEL STIMULATION IN ANY OF THE GROUPS AVAILABLE. THE PATIENT HAD RELOCATED AND WAS IN THE PROCESS OF FINDING A NEW PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. PLEASE REFERENCE MFR REPORT # 3004209178-2011-03526 FOR RELATED NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0166949

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR LEAD: MODEL 3889, LOT# V053525| EXPLANTED:| LOT# NJY107483H| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V053525| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD055203N| IMPLANTED: