BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 4202582 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-01661
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 10, 2013
    Report Date
    September 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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: 1627487-2014-01662. IT WAS REPORTED THE PT EXPERIENCED OVERSTIMULATION IN THE BACK AREA WITH STIMULATION ON SINCE IMPLANT. REPORTEDLY, THE PT HAS FALLEN ON SEVERAL OCCASIONS. DIAGNOSTIC TESTING REVEAL 4 CONTACTS WITH HIGH IMPEDANCES. FURTHERMORE, THE PT ALLEGES POCKET HEATING AND PAIN AT THE IPG SITE WITH STIMULATION ON AND WHILE RECHARGING FOR THE PAST 5 MONTHS. TROUBLESHOOTING WAS ATTEMPTED TO NO AVAIL. F/U IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN, EXPLANTING AND REPLACING THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673948 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 3757242

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other