BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUME TL

    MDR report key: 219322 · Received April 14, 1999

    Report

    Report Number
    6000030-1999-00095
    Event Type
    Injury
    Date Received
    April 14, 1999
    Date of Event
    March 26, 1999
    Report Date
    April 6, 1999
    Manufacturer
    MEDTRONIC INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A SPINAL CORD STIMULATOR IMPLANTED 3/25/1999 AND EXPERIENCED HEAVINESS IN THE LEGS AND PAIN IN THE RIGHT ARM, AS WELL AS DYSURIA. THE LEAD WAS EXPLANTED ON 3/26/1999 AND FOUND TO BE KINKED. THE IMPLANTING PHYSICIAN STATED THE PT'S SYMPTOMS WERE DUE TO PHYSIOLOGICAL SHOCK OF THE SPINAL CORD. ON FOLLOW-UP THE PT WAS RECOVERED WITHOUT SEQUELLAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUME TL Implant SPINAL CORD STIMULATION GZB MEDTRONIC INC. 3986 NAM002133N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O