BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3201882 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-04819
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    EVALUATION RESULTS: THE ACCOMPANIED LEAD WAS CUT INTO TWO SEGMENTS. CONTINUITY TEST SHOWED A FEW CHANNELS WERE ELECTRICALLY OPEN, IT WAS UNK WHETHER IT OCCURRED DURING EXPLANT OR WHILE IT WAS IN THE PT. 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-04023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290608 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 2835619

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other