BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2821113 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-11568
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 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 NO LONGER HAD STIMULATION IN THE LEFT LEG. X-RAYS DETERMINED THE LEAD HAD MIGRATED OFF TO ONE SIDE. IT WAS REPORTED REPROGRAMMING WAS UNABLE TO REGAIN THE SAME STIMULATION COVERAGE. THE PHYSICIAN AND THE PATIENT WERE TO DISCUSS A POTENTIAL SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3258358

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: