BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1132638 · Received August 22, 2008

    Report

    Report Number
    6000030-2008-05162
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    RICE CREK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP AND CATHETER WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REFILL, THE PT COMPLAINED OF A METALLIC TASTE IN HIS MOUTH. IT WAS ALSO REPORTED THAT THE PT STARTED TO EXPERIENCE WITHDRAWAL SYMPTOMS, INCLUDING ITCHING, APPROX 2 HOURS AFTER A REFILL. THE PHYSICIAN GAVE A 75 MCG BOLUS AND THE PT FELT BETTER. AT 3 A.M., THE PT STARTED TO GO THROUGH WITHDRAWAL AGAIN AND RECEIVED ANOTHER 75 MCG BOLUS. THE SYMPTOMS WERE ALLEVIATED BUT NOT FOR AS LONG. THREE HOURS LATER, THE PT WAS AGAIN EXPERIENCING WITHDRAWAL AND A 50 MCG BOLUS WAS GIVEN, WITH NO ALLEVIATION OF SYMPTOMS. THE SPASMS CONTINUED. THE PT WAS GIVEN ANOTHER 50 MCG BOLUS THREE HOURS LATER WHICH DID NOT HELP. ROLLER AND DYE STUDIES WERE NEGATIVE. THE DRUG WAS CHANGED AT THE PUMP POCKET SITE. THE DRUG REMOVED FROM THE PUMP WAS SENT FOR ANALYSIS WHICH REVEALED THAT THE DRUG WAS WITHIN THE SPECIFIED VARIANCE GUARANTEED BY THE MFR. THE PT'S PUMP CONTAINED LIORESAL 2000 MCG/ML. THE PT'S DOSE STARTED OUT AT 185 MCG/DAY OF BACLOFEN, THEN WAS INCREASED TO 205 MCG/DAY, AND THEN AGAIN TO 300 MCG/DAY. AT 300 MCG/DAY, THE PT STARTED EXPERIENCING SLIGHT OVERDOSE SYMPTOMS. THE PT WAS HOSPITALIZED AND BEING MONITORED. THE PT WAS SOMNOLENT WITH A SLIGHTLY DEPRESSED HEART RATE. NO ALARMS WERE NOTED. THE NEXT DAY THE WHOLE SYSTEM WAS CHANGED OUT (CATHETER AND PUMP). THE NEXT MORNING, THE PT "WAS NOT DOING GREAT." THE PT WAS STILL SOMNOLENT AND EXPERIENCED "BURST TYPE EPISODES OF THE UPPER EXTREMITIES". THE CATHETER ACCESS PORT WAS ACCESSED AND CEREBROSPINAL FLUID WAS TAKEN TO BE TESTED. THE PT'S "WHITE COUNTS WERE 100 AND RED WERE 900. PROTEIN AND GLUCOSE WERE NORMAL." THREE DAYS AFTER REPLACEMENT, THE PT WAS FINALLY "STARTING TO NOT HAVE UPPER BODY EPISODES" AND APPEARED TO BE RESPONDING TO THE NEW SYSTEM; THE PT WAS STILL IN THE INTENSIVE CARE UNIT AND NOT FULLY RECOVERED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXPLANTED| PROGRAMMER MODEL PROGRAMMER| CATHETER MODEL 8709