BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2003747 · Received February 23, 2011

    Report

    Report Number
    3007566237-2011-01383
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    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

    IN (B)(6) 2011, THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS OF NAUSEA, TWITCHING AND AGITATION WITH A SLIGHT INCREASE IN PAIN. THERE WAS A MOTOR STALL NOTED ON (B)(6) 2011, IN THE EVENT LOGS; HOWEVER, THE PUMP RECOVERED FROM THAT MOTOR STALL. THE PATIENT'S PUMP WAS REPLACED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709, LOT# N068112020| IMPLANTED: