BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 3192095 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02864
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ST. JUDE MEDICAL NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    IT WAS REPORTED, THE PATIENT HAD HIS SYSTEM EXPLANTED SINCE IT WAS NOT PROVIDING ADEQUATE PAIN RELIEF. THE PATIENT COULD NOT RECALL THE EXPLANT DATE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281099 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3219 2812300

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: