BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2830512 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10202
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED TWO EPISODES OF HOSPITALIZATIONS, ONE IN 2009 AND ANOTHER 2 WEEKS AGO. THE SYMPTOMS WERE SIMILAR TO ACUTE INFECTION, FEVER, IRRITABILITY, INCREASED MUSCLE TONE, VERY HIGH DEGREE OF RHABDOMYOLYSIS, AND VERY HIGH CK LEVELS. THE FIRST EPISODE THE CK LEVELS WERE 100,000 AND REQUIRED DIALYSIS. THE SECOND TIME, THE CK LEVELS WERE 70,000 BUT NO DIALYSIS BECAUSE THEY CAUGHT IT EARLY. ALL SYMPTOMS WERE SIGNS OF WITHDRAWAL. THE PHYSICIAN REPORTED THAT ONLY ONE OTHER TIME THAT THEY KNEW OF WHERE THE PATIENT HAD HIGH CK VALUES 460 (TWICE THE NORMAL). THE FIRST TIME, THE PATIENT RESPONDED BY HIMSELF 3 DAYS LATER. THE SECOND TIME, THEY GAVE ORAL BACLOFEN, PERIACTIN AND FLUIDS, AND HE SEEMED TO GET BETTER. DURING THE FIRST EPISODE, SOME TROUBLESHOOTING WAS PERFORMED. IMAGING TO CHECK FOR DISCONNECTIONS, THE RESERVOIR VOLUMES WERE ACCURATE, AND ASPIRATED CSF THRU THE CATHETER ACCESS PORT. THE CATHETER WAS PATENT. THE PUMP WAS INTERROGATED AND NO STALLS WERE NOTED. THE PHYSICIAN WAS UNSURE IF THE LOGS WERE READ. THE PATIENT WAS GETTING REFILLED EARLY, 3 TO 4 WEEKS BEFORE THE REFILL WAS DUE. THE MOM STATED THE PATIENT WAS GETTING A LITTLE MORE SPASTIC SO THEY REFILLED EARLY. A DYE STUDY WAS NOT DONE. IT WAS DISCUSSED CHECKING LOGS TO CONFIRM NO INTERMITTENT STALLS AND RECOVERIES OCCURRED. TO THE PHYSICIAN'S KNOWLEDGE, THAT HAD NOT BEEN DONE YET. HE WILL CHECK WITH THE OTHER PHYSICIAN TO CONFIRM. THERE WAS NO CURRENT STALL AT THE LAST TELEMETRY. BECAUSE OF THE ABRUPT STOPPAGE AND SPONTANEOUS RECOVERY, THEY WERE NOT THINKING THIS WAS A CATHETER PROBLEM. THEY WERE THINKING IT WAS EITHER AN INTERMITTENT PUMP FAILURE OR A DISEASE THEY HAVE NOT HEARD OF. THEY WERE TRYING TO DETERMINE IF THIS WAS PUMP RELATED OR NOT. THEY HAD DONE EXTENSIVE TESTS UNRELATED TO THE PUMP INCLUDING MUSCLE BIOPSIES LOOKING FOR MITOCHONDRIAL DISEASES, ETC. THEY HAVE DONE A COMPLETE HISTORY ON THE PATIENT, PULLED ALL NOTES FROM PREVIOUS HOSPITALIZATIONS AND ALL UNIVERSITIES IN AN EFFORT TO TRY TO RESEARCH WHY THIS WAS HAPPENING. THE PATIENT DIAGNOSIS WAS SPASTIC QUADRIPARESIS, SEVERE RETARDATION, CP FROM PREMATURE GESTATION. THE PUMP WAS DELIVERING LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization