BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2843476 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-13085
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 25, 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 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 HAS NOT RECEIVED EFFECTIVE STIMULATION COVERAGE OF HIS PAIN AREA SINCE BEING IMPLANTED WITH THE SCS SYSTEM. THE PT STATED, HE WOULD LIKE THE SCS SYSTEM REMOVED. A SJM REP TO FOLLOW-UP WITH PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3776049

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788