BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1002290 · Received February 22, 2008

    Report

    Report Number
    6000030-2008-00899
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    January 25, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT HE OVERDOSED THREE TIMES, PASSED OUT, AND HIT HIS HEAD (DATES NOT SPECIFIED). OTHER PT SYMPTOMS INCLUDED NEVER HAVING THERAPEUTIC EFFECTS SINCE IMPLANTATION AND FEELING ACHY AND SWEATY. HIS TEETH HAD DECAYED AND HALF OF THEM WERE REMOVED. THE PT REPORTED THAT VARIOUS COMPUTERIZED TOMOGRAPHY SCANS AND MAGNETIC RESONANCE IMAGING HAD INDICATED THAT THE PUMP WAS WORKING FINE (TEST DATES NOT REPORTED). THE DRUGS INSIDE THE PUMP HAD BEEN CHANGED MANY TIMES AND HAD BEEN INFUSING AT THE MAXIMUM RATE WITHOUT PAIN RELIEF. THE PT REPORTED HE SLEPT 12-16 HRS A DAY FOR A PERIOD OF TWO YRS, EVEN AFTER THE DRUGS IN HIS PUMP WERE CHANGED. THE PT HAD BEEN ON MANY ORAL DRUGS WHILE ON THE PUMP INCLUDING NEURONTIN, TIZANIDINE, SEROQUEL, ALTACE, REGLAN, DILAUDID, ANDROGEL, OXYCONTIN, VICODEN, ADDERALL, AND PROZAC. THE HCP REPORTED THAT THE PT HAD ONLY SALINE IN HIS PUMP, AND IT WAS TURNED DOWN SO LOW THAT OVERDOSE WAS NOT POSSIBLE; THE HCP PLANNED TO EXPLANT THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED| CATHETER MODEL 8731 LOT# B005539N47| IMPLANTED| EXPLANTED