BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 CHANNEL, TRIAL, 60 CM

    MDR report key: 2220243 · Received August 16, 2011

    Report

    Report Number
    1627487-2011-07062
    Event Type
    Injury
    Date Received
    August 16, 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

    EVALUATION: RESULTS - THE DEVICE WAS TESTED AND PASSED ALL FUNCTIONAL (CONTINUITY AND RESISTIVITY) TEST. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2011 AND DURING PROCEDURE, IT WAS FOUND BY THE DOCTOR THAT THE IMPEDANCES WERE INVALID. A NEW LEAD WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT HAD STIMULATION.

    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 3376707

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention