BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 4092022 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-01557
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT # 1627487-2014-01556. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE COVERAGE IN THE DESIRED AREA. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING AND REPLACING THE SCS SYSTEM WITH A COMPETITOR'S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518720 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3286 3416664

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SCS IPG, MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)