BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 1895455 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03522
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO FUNCTIONAL TESTING WAS PERFORMED AS ONLY A PARTIAL LEAD WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION FOUND THE WIRE TO CHANNEL 11 WAS BROKEN INSIDE THE CONTACT; HOWEVER, IT IS NOT POSSIBLE TO DETERMINED WHEN THIS BREAK OCCURRED. 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

    IT WAS REPORTED THE PT HAD AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, IMPLANTED. THE PT REPORTED THAT SINCE A RECENT FALL, HIS STIMULATION IS NOT THE SAME. AN X-RAY OF THE PT'S SYSTEM WAS TAKEN BUT SHOWED NO ANOMALIES. THE LEAD WAS EXPLANTED AND REPLACED. NEITHER THE LOT NUMBER NOR THE IMPLANT DATE WERE PROVIDED; THEREFORE, NO MFG OR EXPIRATION DATE COULD BE DETERMINED. THE EXPLANTED LEAD WAS RETURNED TO THE MFR FOR ANALYSIS. FOLLOW UP ON THE PT FOUND THAT HE IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention