BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 2120953 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00783
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 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: AS RECEIVED THE RETURNED LEAD FAILED FUNCTIONAL TESTING FOR CONTINUITY. ANALYSIS REVEALED THAT THE DEVICE HAS AN OPEN CHANNEL (#3). 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 AN SCS SYSTEM INCLUDING A SURGICAL LEAD FOR BACK AND BILATERAL LEG PAIN ON (B)(6) 2011. IT WAS REPORTED THAT THE PT WAS ONLY FEELING STIMULATION IN HER ABDOMEN. THIS TISSUE REPORTEDLY BEGAN A FEW DAYS FOLLOWING THE IMPLANT. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEAD WITH A DIFFERENT MODEL. ADDITIONALLY, THE NEW DEVICE WAS PLACED AT A DIFFERENT VERTEBRAE LEVEL THAN THE ORIGINAL LEAD. EFFECTIVE STIMULATION WAS CAPTURED FOR THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3136792

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788| IMPLANT:| SCS LEAD: MODEL 3163