BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1853880 · Received September 7, 2010

    Report

    Report Number
    3007566237-2010-06807
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 9, 2010
    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

    A CATHETER FRACTURE WAS REPORTED, AND THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. AN AUDIBLE CRITICAL ALARM OCCURRED, AND THE PUMP WENT INTO SAFE STATE. PUMP LOGS CONFIRMED THE RESET AND ALSO LOW BATTERY. TELEMETRY HAD CONFIRMED THE ALARM. LIORESAL WAS ADMINISTERED BY THE PUMP. CONCENTRATION AND DOSE RATE OF THE MEDICATION WAS NOT REPORTED. A REVISION / REPLACEMENT SURGERY WAS PLANNED IN REGARDS TO BOTH THE CATHETER AND PUMP. THE PATIENT'S STATUS / OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 28 YR EXPLANTED:| CATHETER: MODEL 8575, LOT# J12221R| IMPLANTED:| CATHETER: MODEL 8709, LOT# J12166R03| EXPLANTED:| IMPLANTED: