BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2926384 · Received January 16, 2013

    Report

    Report Number
    1627487-2013-04070
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT MET WITH THE SJM REPRESENTATIVE FOR REPROGRAMMING, AND THE SYSTEM WAS NOT PROVIDING FULL STIMULATION COVERAGE. IT WAS REPORTED, THE PHYSICIAN FELT THE LEAD WAS NOT POSITIONED LOW ENOUGH FOR THE NEEDED COVERAGE. THE PHYSICIAN REPOSITIONED THE LEAD ON (B)(6) 2012. IT WAS REPORTED THE PHYSICIAN MOVED THE LEAD DOWN ONE VERTEBRAL LEVEL AND SLIGHTLY MIDLINE WHICH PROVIDED PROPER STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23505 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3810220

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG, MODEL 3788| IMPLANT DATE: