BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3031971 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15413
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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

    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: 1627487-2013-15414. IT WAS REPORTED THE PT IS EXPERIENCING OVER-STIMULATION IN HER LEGS. THE PT STATED WHEN SHE TURNED HER IPG ON, THE STIMULATION CAUSED SPASMS IN HER RIGHT LEG AND BACK. SJM REP MET WITH THE PT AND ALL CONTACTS SHOWED NORMAL IMPEDANCES. THE SJM REP INDICATED A LOW BATTERY FLAG WAS RECEIVED AND CLEARED. THE PT INDICATED SHE HAD NOT USED OR CHARGED HER SYSTEM IN APPROX 3 MONTHS. ALTHOUGH, REPROGRAMMING WAS ABLE TO PROVIDE ADEQUATE STIMULATION COVERAGE, THE PT REQUESTED THAT HER SCS SYSTEM BE REMOVED. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128175 LAMITRODE TRIPOLE 16 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3219 2812286

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention