BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3781427 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08271
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED ALARM ANOMALY, RESONATOR ANOMALY. ALL PUMP LOGS ARE CLEAN MEANING NO MOTOR STALLS, MOTOR STALLS RECOVERIES, OR ERRORS OF ANY KIND WERE EVER RECORDED. THE PUMP FAILED THE ALARM TEST WITH A DB LEVEL OF 67.7 DB. MINIMUM SPEC. IS 70.0 DB. A CRACK WAS FOUND ON THE RESONATOR, WITH NO TOP SHIELD DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED ERI OCCURRED AND THE PUMP WAS PROPHYLACTICALLY REMOVED TO AVOID IN-VIVO BATTERY DEPLETION. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260545 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR