BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3201796 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-05910
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 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 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. REF MFR REPORT: 1627487-2013-05911. IT WAS REPORTED, THE PT EXPERIENCED OVERSTIMULATION ON A COUPLE OF OCCASIONS AFTER STIMULATION WAS ACTIVATED. AS A RESULT, THE PT HAS CHOSEN TO NOT USE HER SCS SYSTEM. IT WAS ALSO REPORTED THE PT HAD DIFFICULTY COMMUNICATING WITH THE IPG USING THE CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289691 LAMITRODE TRIPOLE 16C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3214 115673

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other