BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1162108 · Received September 16, 2008

    Report

    Report Number
    6000030-2008-05818
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    July 24, 2008
    Report Date
    August 20, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PUMP REPLACEMENT AND CATHETER REVISION. NO REASON WAS PROVIDED FOR THE REPLACEMENT AND REVISION. NO PT SYMPTOMS OR OUTCOME WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, 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 60 YR Required Intervention CATHETER MODEL 8709 LOT# L67850 IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK