BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 4132712 · Received September 29, 2014

    Report

    Report Number
    1627487-2014-15702
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    THE PT REPORTED "WIRES MAY HAVE COME LOOSE" AFTER SUFFERING FALLS. THE PT STATED X-RAYS WERE TAKEN AND CONFIRMED A LEAD MIGRATION. THE PT FURTHER STATED HER PHYSICIAN DECLINED TO EXPLANT HER SYSTEM AND SHE IS NOW USING A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT. THE PT DOES NOT WISH TO PURSUE FURTHER INTERVENTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604950 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 113671

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other IMPLANT DATE:| SCS IPG, MODEL 3716,