BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1842003 · Received September 21, 2010

    Report

    Report Number
    3007566237-2010-07139
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS, FOLLOWING A MAJOR ABDOMINAL SURGERY THAT TOOK PLACE ON (B)(6) 2010. THE FOLLOWING SYMPTOMS OCCURRED: ALERTED MENTAL STATUS, AND ITCHING. LATER, ON (B)(6) 2010, IT WAS FURTHER REPORTED THAT A MOTOR STALL; WITH NO MOTOR STALL RECOVERY HAD BEEN CONFIRMED VIA THE PUMP'S EVENT LOGS. THE MOTOR STALL WAS CONSTANT. AN AUDIBLE CRITICAL ALARM WAS HEARD ON WAS WEEKEND FOLLOWING THE SURGERY. THE ALARM WAS CONFIRMED BY TELEMETRY. SAFE STATE / RESET IN THE PUMP LOGS WAS ALSO CONFIRMED. THE FOLLOWING ADDITIONAL SYMPTOMS WERE REPORTED: INCREASED HEART RATE, INCREASED SPASTICITY, DECREASED BLOOD PRESSURE, AND A BODY TEMPERATURE OF 100.9. IT WAS NOTED THAT THE PATIENT HAD BEEN IN THE HOSPITAL SINCE THE ABDOMINAL SURGERY, AND WAS PLACED ON VALIUM (15 MG BOLUSES) FOR "THE PAST FEW DAYS WITHOUT RESOLVE." A COMPANY REPRESENTATIVE WAS PLANNING TO INTERROGATE THE PUMP. THE PATIENT'S OUTCOME, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 26 YR Hospitalization EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11638R46