BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1062907 · Received June 19, 2008

    Report

    Report Number
    6000030-2008-03355
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 22, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A FALL AND THAT THE PUMP POCKET WAS "EXTREMELY LOOSE". IN TWO MONTHS LATER, THE PT HAD A REFILL AND INDICATED SYMPTOMS WERE STILL PRESENT. A REVISION HAD TAKEN PLACE (DATE AND SPECIFIC REVISION DETAILS UNKNOWN). THREE WEEKS LATER, THE PT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT, LEFT SIDE AND FOOT NUMBNESS AND PAIN OVER THE PUMP POCKET AND NEAR THE CATHETER PATHWAY. THE PUMP REPORTEDLY MOVES IN THE POCKET. THE SYMPTOMS STARTED 5 TO 6 MONTHS EARLIER. ADDITIONAL INFO RECEIVED INDICATED THE DRUG USED IN THE PUMP WAS DILAUDID 20 MG/ML AND BUPIVICAINE 15 MG/ML AT A DOSE OF 5.5 MG/DAY. THE PATIENT'S PAIN WAS WORSENING DUE TO OPIOD TOLERANCE. AN X-RAY AND CATHETER STUDY PERFORMED IN 2008 WERE NEGATIVE FOR ISSUES.

    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 Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| IMPLANTED:| CATHETER MODEL 8709 LOT# J11634R30| EXPLANTED: