BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3012186 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-13286
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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 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: 1627487-2013-13285. IT WAS REPORTED THE PT FEELS WHAT HE DESCRIBES AS A "SHOCK" ALL OVER HIS BODY WHEN HE TURNS THE PROGRAMMER ON. IT WAS NOTED THE "SHOCKS" ARE SIMULTANEOUS WITH THE BEEPS THE PROGRAMMER MAKES WHEN IT'S COMMUNICATING WITH THE IPG. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106371 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3504561

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention