BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2062818 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02131
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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

    THERE WERE MULTIPLE CONFIRMED MOTOR STALLS AND RECOVERIES THAT WERE NOTED IN THE EVENT LOGS OVER THE LAST 2 MONTHS, AND CURRENTLY, THE PT'S PUMP WAS STALLED. THE PT WAS "UNDERDOSED", BUT NO SPECIFIC SYMPTOMS WERE REPORTED. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BACLOFEN 450MCG/ML AND SUFENTANIL 900 MCG/ML. 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# J11423R69| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8578, LOT# N153155| EXPLANTED: