BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3231445 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00386
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODES: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: COMPLAINT WAS CONFIRMED FOR "LEAD BROKEN/FRACTURED". MICROSCOPIC INSPECTION OF THE RETURNED LEAD REVEALED BROKEN WIRES 16.5CM DISTAL TO THE STIMULATION END. THE BROKEN WIRES WERE CONSISTENT WITH AN OVERSTRESS CONDITION THE LEAD WAS SUBJECTED TO WHILE IMPLANTED. 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 (B)(6) LOST STIMULATION. SURGICAL INTERVENTION WAS UNDERTAKEN TO ADDRESS THIS MATTER, AND IT WAS FOUND THAT THE LEAD WAS FRACTURED. AS SUCH THE DEVICE WAS EXPLANTED AND REPLACED. POST-OPERATIVE PROGRAMMING IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324717 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL: 1192