BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202651 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-02779
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    May 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED BASELINE SPASTICITY. IN (B)(6) 2012, THE PATIENT WAS IN THE HOSPITAL FOR A URINARY TRACT INFECTION AND WAS NEARING THE LOW RESERVOIR ALARM. THE ATTENDING HCP DID NOT HAVE PRIVILEGES TO REFILL HER PUMP SO THEY DECREASED DOSAGE TO INCREASE THE TIME UNTIL THE LOW RESERVOIR ALARM WOULD OCCUR. AN HCP THEN REFILLED THE PUMP ON (B)(6) 2012 AND INCREASED HER DOSE SOME BUT NOT BACK TO WHAT IT WAS PRIOR TO THE UTI. LATER THE PATIENT WAS MOVED TO AN ACUTE REHAB FACILITY AND THE HCP WANTED TO INCREASE HER DOSE AGAIN DUE TO SEVERE SPASTICITY BUT THE HCP DID NOT HAVE PRIVILEGES THERE. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302198 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR