BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1213067 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06830
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LUMBAR SEQUENCE MRI THAT WAS STOPPED AFTER ONLY 5 MINUTES OF MAGNETIC EXPOSURE BECAUSE THE PATIENT "FELT HOT ALL OVER HER BODY". WHEN THE HCP ASKED IF SHE WAS HOT OVER HER PUMP, THE PATIENT SAID, "NO, IT'S ALL OVER". THE PATIENT HAS HAD MRIS IN THE PAST AND HAD NEVER REPORTED TEMPERATURE CHANGES, OR ANY PROBLEMS WITH THEM. THE PATIENT'S BODY TEMPERATURE WAS NOT ACTUALLY CONFIRMED OR TAKEN WITH AN ORAL THERMOMETER. IT WAS CONFIRMED THAT THE MRI WAS WITH A 1.5 TESLA MAGNET. THE PUMP CONTAINED DILAUDID. THE HCP WHO MANAGES THE PATIENT'S PUMP BELIEVED THAT WOULD NOT BE CAUSED BY THE INTRATHECAL DILAUDID THE PATIENT WAS RECEIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR EXPLANTED:| CATHETER: MODEL 8709SC| IMPLANTED:| ACCESSORY: MODEL 8590-1| PROGRAMMER: MODEL 8840| IMPLANTED:| EXPLANTED: