BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 8

    MDR report key: 3110586 · Received May 10, 2013

    Report

    Report Number
    1627487-2013-03641
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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'S SCS LEAD WAS REPLACED DUE TO INTERMITTENT STIMULATION. IT WAS ALSO REPORTED DURING THE REPLACEMENT PROCEDURE THE LEAD APPEARED TO BE CRACKING AS IT NEARED THE INSERTION OF THE SCS IPG HEADER. SUBSEQUENTLY, THE SCS IPG WAS ALSO REPLACED TO ENSURE FUNCTIONALITY. FOLLOW-UP IDENTIFIED THE ISSUE RESOLVED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205993 LAMITRODE TRIPOLE 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3208 40277

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788