BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3931727 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-06170
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ST JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULT: THE COMPLAINT OF LEAD BROKEN/FRACTURED FROM THE FIELD WAS CONFIRMED. THE LEAD HAD A KINK WITH ALL INTERNAL WIRES BROKEN, AND A CAM IMPRESSION FROM A SWIFT-LOCK ANCHOR 10MM FROM THE FRACTURE. THIS FRACTURE AT THE PROXIMAL END OF THE SWIFT-LOCK ANCHOR IS CONSISTENT WITH AN OVER STRESS CONDITION THE LEAD WAS SUBJECTED TO WHILE STILL IN VIVO. 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

    IT WAS REPORTED THE PATIENT (B)(6) WAS NOT RECEIVING STIMULATION. LEAD DIAGNOSTICS SHOWED HIGH IMPEDANCES. THE PATIENT UNDERWENT REVISION SURGERY WHERE HER LEAD WAS REPLACED WITH A NEW ONE. MULTIPLE LEAD FRACTURES WERE OBSERVED DURING SURGERY. THE PATIENT IS NOW RECEIVING STIMULATION AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367136 LAMITRODE S8 SCS LEAD GZB ST JUDE MEDICAL NEUROMODULATION 3286 4000140

    Patients

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