BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2062825 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02150
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CONFIRMED PUMP MOTOR STALL WITH NO MOTOR STALL RECOVERY WAS REPORTED. A PUMP TUBE SET HAD OCCURRED. THE PUMP HAD ALARMED. THE PT HAD AN MRI; IT IS UNK IF THE DATE OF THE MRI COINCIDED WITH THE DATE OF THE MOTOR STALL. THE PT HAD BEEN ON ORAL MEDICATIONS FOR OTHER INJURIES SO THE SYMPTOMS WERE NOT CLEAR. THE PUMP WAS USED TO DELIVER MORPHINE. 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 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR IMPLANTED:| CATHERER: MODEL 8709, LOT# J11989R30| EXPLANTED: