BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 4852811 · Received June 18, 2015

    Report

    Report Number
    1627487-2015-25107
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EXPERIENCING INEFFECTIVE STIMULATION DUE TO LEAD MIGRATION. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPOSITION THE LEAD WHICH RESOLVED THE ISSUE. ADDITIONALLY, IT WAS REPORTED THE PATIENT'S ANCHOR WAS EXPLANTED AND REPLACED DURING THE PROCEDURE DUE TO AN ALLEGED FRACTURE WHICH HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398765 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4802416

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other MODEL: 1192, SCS ANCHOR