BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCRHOMED II

    MDR report key: 1812127 · Received August 17, 2010

    Report

    Report Number
    3007566237-2010-06176
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A CONFIRMED MOTOR STALL WAS NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. IT WAS NOTED MOTOR STALL CAUSED BY PATIENT HAVING HAD AN MRI. THE PUMP HAD NOT RECOVERED 3.5 HOURS POST MRI. HCP PROGRAMMED THE PUMP TO MINIMUM RATE AND SENT PATIENT HOME. PUMP WILL BE RECHECKED FOR MOTOR STALL RECOVERY. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596, LOT# N075715035| EXPLANTED:| CATHETER: MODEL 8709, LOT# N081104011