BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023467 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01749
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 21, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PENDING ALARM WAS REPORTED FROM (B)(6) 2010; THE ALARM WAS DISCOVERED BY THE HCP IN A PT WHOSE PUMP WAS IMPLANTED ON (B)(6) 2010. A MOTOR STALL OCCURRED AND WAS NOTED IN THE EVENT LOGS ON (B)(6) 2010 AT 1043 AND LATER RECOVERED THAT DAY AT 1658. THE PT "NEVER HAD THERAPEUTIC EFFECT SINCE IMPLANT." THE HCP HAD TITRATED THE PT'S DOSE UP FROM 0.1 TO 3.795 MG/DAY WITHOUT ANY RELIEF. THE PT WAS FOLLOWING UP WITH THEIR PHYSICIAN IN (B)(6) 2011. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT N247276002| EXPLANTED: