BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS 60-CM TRIAL SCS LEAD

    MDR report key: 2210421 · Received August 9, 2011

    Report

    Report Number
    1627487-2011-04018
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HIS TRIAL SCS SYSTEM, INCLUDING TWO TRIAL LEADS AND A MULTIPROGRAM TRIAL STIMULATOR DEVICE ON (B)(6) 2011. DURING THE TRIAL PERIOD, IT WAS REPORTED BY THE PHYSICIAN THAT THE PT WAS DRIVING WITH HIS STIMULATOR ON AND WAS IN AN AUTOMOBILE ACCIDENT. ON (B)(6) 2011, THE PHYSICIAN REMOVED THE TRIAL LEADS AND DISCARDED THEM. IT IS REPORTED THE PT RECEIVED RIB AND FACIAL INJURIES DURING THE ACCIDENT AND IS FOLLOWING UP WITH HIS PCP FOR THESE ISSUES. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS 60-CM TRIAL SCS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MTS TRIAL STIMULATOR: MODEL UNK