BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3864156 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11315
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS IN REHAB BECAUSE, THEIR LEGS WERE REALLY BAD AND THE PATIENT COULDN¿T WALK VERY WELL. IT WAS NOTED THEY THOUGHT IT MIGHT BE RELATED TO THE DEVICE/THERAPY. IT STARTED SHORTLY AFTER THE PATIENT "GOT IT". THE PATIENT STARTED "HAVING DIFFICULTY" AND IT MAY HAVE HAD NOTHING TO DO WITH IT AT ALL BUT, THE HEALTHCARE PROFESSIONALS (HCP) THOUGHT IT HAD AN EFFECT ON IT. IT WAS NOTED, THE "DIFFICULTY" STARTED ABOUT A YEAR AFTER HE GOT "IT" [PUMP]. WHILE THE PATIENT WAS IN REHAB, A UTI (URINARY TRACT INFECTION) STARTED. THE PATIENT WENT TO THE HOSPITAL A DAY AND A HALF AGO BECAUSE OF THE UTI AND "OUT OF HIS MIND" CONFUSION. IT WAS NOTED THEY WERE TRYING TO GET HIM TO "STRAIGHTEN" UP SO HE COULD TAKE THERAPY. THE PUMP CONTAINED BUPIVACAINE AND DILAUDID (HYDROMORPHONE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337813 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention