BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1971030 · Received January 6, 2011

    Report

    Report Number
    3007566237-2011-00131
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED MOTOR STALL OCCURRED ON (B)(6) 2010; AND TWO DAYS LATER A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" OCCURRED. THERE WAS NO MOTOR STALL RECOVERY RECORDED. THE PT HAD NOT HAD A RECENT MRI. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BACLOFEN AND HYDROMORPHONE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# J11926R21| IMPLANTED: