BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 CHANNEL, TRIAL, 60 CM

    MDR report key: 2230419 · Received August 15, 2011

    Report

    Report Number
    1627487-2011-07057
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 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

    EVAL, RESULTS: THE DEVICE WAS TESTED AND PASSED ALL FUNCTIONAL (CONTINUITY AND RESISTIVITY) TEST. 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 A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO IMPLANT A TRIAL LEAD BUT IT EXHIBITED HIGH IMPEDANCES. SEVERAL ATTEMPTS WERE MADE TO REPOSITION THE LEAD TO NO AVAIL. THE DOCTOR DECIDED TO IMPLANT A NEW LEAD, THE ISSUE WAS RESOLVED AND IMPEDANCES WERE ALL WITHIN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 CHANNEL, TRIAL, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3350862

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention