BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3110882 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-12633
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT WAS NOT RECEIVING COVERAGE ON THE LEFT LEG AND WAS GETTING UNINTENDED STIMULATION ON THE RIGHT LEG. X-RAYS REVEALED THE LEAD MIGRATED. ON (B)(6) 2013, THE PHYSICIAN MOVED THE LEAD AND THE PT IS RECEIVING EFFECTIVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204941 PENTA SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3228 3903752

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention