BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3141283 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-01586
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 10, 2012
    Report Date
    May 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 PT WAS EXPERIENCING PRESSURE THAT RADIATED FROM HER LEAD IMPLANT TO THE FRONT OF HER CHEST. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT'S ENTIRE SCS SYS WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231732 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 3543757

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3768