BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY

    MDR report key: 708972 · Received May 5, 2006

    Report

    Report Number
    6000032-2006-00737
    Event Type
    Other
    Date Received
    May 5, 2006
    Report Date
    April 7, 2006
    Manufacturer
    MEL REL, INCORPORATED
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ATTORNEY REPORTS "A NEUROSTIMULATOR, INCLUDING A MODEL 7427 IPG, 3487A LEADS, AND 7489-25 EXTENSIONS WERE IMPLANTED IN PLAINTIFF BY THE SURGEON IN 2003 FOR THE TREATMENT OF BACK PAIN, AN ADDITIONAL NEUROSTIMULATOR WAS IMPLANTED EIGHT MONTHS LATER. SHE CONTINUED TO COMPLAIN OF PAIN FOLLOWING THE IMPLANTS, AND EXPERIENCED SEVERAL COMPLICATIONS FOLLOWING THE IMPLANTS, INCLUDING INFECTION FOLLOWING THE SECOND IMPLANT, THE LEADS COULD NOT BE EXPLANTED BECAUSE THEY "WERE PLACED SO CLOSE TO THE SPINAL CORD THAT NOT ALL OF THE LEADS COULD BE SAFELY REMOVED WITHOUT RISK OF PARALYSIS" AND THAT PLANTIFF HAS CONTINUING MEDICAL COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY IPG LGW MEL REL, INCORPORATED 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other