BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1242967 · Received November 21, 2008

    Report

    Report Number
    6000030-2008-07676
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 27, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP REPLACEMENT DUE TO BATTERY DEPLETION. THE CATHETER WAS ALSO REPLACED AT THAT TIME DUE TO AN UNSPECIFIED "MALFUNCTION". NO PATIENT SYMPTOMS WERE REPORTED. THE EXPLANTED CATHETER WAS COMPRISED OF 2 DIFFERENT CATHETER SEGMENTS; ONE OF THEM WAS FROM A DIFFERENT MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention MODEL# 82-1706| CATHETER: MODEL 8703W| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| EXPLANTED:| CATHETER: MODEL CODMAN LUMBAR CATHETER: