BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3082231 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06991
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 26, 2013
    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). FINAL ANALYSIS OF THE PUMP FOUND THAT THE MOTOR CAN TOP BRIDGE PLATE WAS NOT TOUCHING PUMP HEAD COVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO THE ELECTIVE REPLACEMENT INDICATION (ERI). THERE WAS NO INJURY AND PATIENT RECOVERED WITHOUT SEQUELA. THE DRUG USED IN THE PUMP WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185601 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1