BEUDAMED
    FDA Adverse Event Other Summary report: N

    6000032-1997-00117

    MDR report key: 90623 · Received May 9, 1997

    Report

    Report Number
    6000032-1997-00117
    Event Type
    Other
    Date Received
    May 9, 1997
    Date of Event
    August 22, 1996
    Product Code
    GZB
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    THE REPORTER'S INFORMATION IS INCONSISTENT WITH MFR'S RECORDS. DEVICE REGISTRATION INFORMATION INDICATES THIS DEVICE WAS IMPLANTED FOR TREATMENT OF CHRONIC INTRACTABLE PAIN OF THE LIMBS AND TRUNK. THIS IS INFORMATION TO REFUTE THE IMPLICATION IN B5 THAT THE DEVICE MAY HAVE CAUSED A LUMBER NERVE ROOT INJURY. IT IS ALSO ILLOGICAL THAT A PATIENT WOULD REPLACE A DEVICE WHICH HAD CAUSED SUCH AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GZB

    Patients

    Seq Age Sex Outcome Treatment
    1 *