BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3326251 · Received August 19, 2013

    Report

    Report Number
    1627487-2013-19182
    Event Type
    Injury
    Date Received
    August 19, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 # 1627487-2013-191821 IT WAS REPORTED THE PT FELT "HIS BODY WAS REJECTING THE SCS SYSTEM." THE PT ALSO HAD PAIN IN HIS HANDS. THE PT HAD THE SCS SYSTEM EXPLANTED, DATE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399385 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3715845

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other