BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2643872 · Received July 6, 2012

    Report

    Report Number
    3004209178-2012-05305
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Report Date
    June 4, 2012
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V000591, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) PERFORMED LAST FRIDAY DUE TO TREMORS. GUIDELINES WERE OBTAINED PRIOR TO THE MRI AND THE DEVICE WAS TURNED OFF PRIOR TO THE SCAN. LESS THAN 10 MINUTES INTO THE SCAN THE PATIENT FELT A SHARP SHOOTING PAIN ON HER LEFT SIDE, THEN IT WENT NUMB, AND THE PATIENT COULD NOT WALK. WHEN THE PATIENT WAS OUT OF THE SCANNER IT TOOK 20-30 MINUTES FOR HER TO RECOVER. THE PATIENT WAS STILL HAVING BAD HEADACHES AND HER LEFT SIDE WAS STILL SORE. THE DEVICE HAD NOT BEEN TURNED BACK ON SINCE THE MRI, AND THE PATIENT DID NOT KNOW IF IT EVEN WORKED NOW. THE REPORTER WANTED TO KNOW IF THE DEVICE CAUSED THE ISSUES WITH THE MRI BECAUSE THE PATIENT WAS LYING ON HER BACK AND PRESSING ON THE DEVICE DURING THE SCAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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