BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1151543 · Received September 4, 2008

    Report

    Report Number
    6000030-2008-05450
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    January 1, 2005
    Report Date
    December 14, 2005
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. CATHETER.

    Description of Event or Problem · 1

    THE PT'S WIFE REPORTED THAT THE PT PREVIOUSLY HAD A CATHETER COMPLICATION WHICH TOOK QUITE SOME TIME TO FIX. THE HEALTH CARE PROFESSIONAL STATED THAT THE PT'S CATHETER WAS REPLACED IN 2005 BECAUSE IT WAS BROKEN AT THE POINT OF ENTRY INTO THE INTRATHECAL SPACE. THE PT HAD EXPERIENCED A SLIGHT INCREASE IN TIGHTNESS. A PLAIN FILM X-RAY WAS DONE (DATE NOT REPORTED) THAT SHOWED THE BREAK, NO OTHER STUDIES WERE DONE. THE CATHETER WAS REPLACED; THE DISTAL PORTION OF THE CATHETER WAS LEFT IN THE INTRATHECAL SPACE AT THE TIME OF THE REPLACEMENT. THE PT HAD BEEN FINE SINCE THE REPLACEMENT WITH ONLY INTERMITTENT ADJUSTMENTS IN DOSAGE. THE MEDICATION IN THE PUMP WAS LIORESAL 2000MCG/ML.

    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 47 YR Required Intervention IMPLANTED| CATHETER MODEL 8709 LOT# J11536R23| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK