BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 1091705 · Received August 1, 2008

    Report

    Report Number
    6000030-2008-04572
    Event Type
    Death
    Date Received
    August 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT (INCREASED SPASTICITY). THE PT WAS RECEIVING 180 MCG/DAY OF BACLOFEN AND WAS HAVING SPASTICITY IN THE LOWER REGION OF THE BODY. THE PHYSICIAN RECENTLY INCREASED THE DAILY DOSE TO 250 MCG/DAY, ON THE SAME DAY, THE PT BECAME VERY RIGID. THE PT WAS ADMITTED TO THE ER. IT WAS UNK IF THE SYMPTOMS WERE RELATED TO THE PUMP OR OTHER MEDICAL COMPLICATIONS. IT WAS INDICATED THAT DIAGNOSTICS WERE GOING TO BE PERFORMED. THE HEALTH CARE PROVIDER RESPONDED TO F/U BY INDICATING THAT THE CAUSE OF THE INITIAL EVENT WAS A URINARY TRACT INFECTION. NO OTHER SIGNS OR SYMPTOMS WERE REPORTED, BUT IT WAS INDICATED THAT THE PT OUTCOME WAS DEATH. DATE AND CAUSE OF DEATH WERE NOT REPORTED. IT WAS LATER REPORTED THAT THE PT HAD MULTIPLE CO-MORBIDITIES INCLUDING DEEP BRAIN STIMULATION SYS IMPLANTED FOR ESSENTIAL TREMOR. PER THE REPORTER, THE PT MAY HAVE CONTRACTED PNEUMONIA. THE PT HAD DEVELOPED SWALLOWING PROBLEMS. IT IS UNK IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R IMPLANTED| CATHETER MODEL 8709 LOT#N102048033| PROGRAMMER MODEL PROGRAMMER| EXPLANTED