BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C LEAD, 60CM LENGTH

    MDR report key: 2091652 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-00581
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00582. THE PT REC'D AN SCS SYSTEM INCLUDING A SURGICAL LEAD AND PERCUTANEOUS LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PT SUFFERED A FALL AND AFTERWARDS HER STIMULATION PATTERN CHANGED. EFFORT TO RECAPTURE EFFECTIVE THERAPY VIA REPROGRAMMING YIELDED LIMITED SUCCESS. AN X-RAY REVEALED A BEND IN ONE OF THE LEADS AND A POSSIBLE LEAD FRACTURE. A SUBSEQUENT DIAGNOSTIC TEST FOUND INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEADS, AND EFFECTIVE THERAPY WAS RECAPTURED AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3245 2884823

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: