BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2844485 · Received November 16, 2012

    Report

    Report Number
    1627487-2012-02691
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    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 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 NOT GETTING STIMULATION COVERAGE TO HER LEFT LEG AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS REVEALED THE LEAD HAD MIGRATED SLIGHTLY TO THE RIGHT. IT WAS REPORTED SURGICAL INTERVENTION WILL MOST LIKELY BE UNDERTAKEN 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 3416810

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED: