BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3151567 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08777
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CATHETER MODEL: 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: UNK; PROGRAMMER MODEL: 8840, SERIAL # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN MRI FOR OTHER MEDICAL REASONS UNRELATED TO THE DEVICE, A CONFIRMED MOTOR STALL WAS NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED AT THE TIME OF INTERROGATION. PUMP LOGS READ MOTOR STALL OCCURRED (B)(6) 2013 AT 13:27 AND THERE WAS NO RECOVERY. DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN. IT WAS LATER REPORTED THAT THE PUMP RECOVERED WITHOUT INCIDENT. REPORTER DIDN¿T KNOW EXACTLY WHEN IT RECOVERED BUT IT WAS INTERROGATED THE NEXT DAY AND HAD RECOVERED. PATIENT REPORTED NO ALARMS AND NO CHANGE IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252559 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR