BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3192050 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-15832
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    DEVICE 2 OF 2. REF MFR REPORT: 1627487-2013-15831. THE PT REPORTED HE WANTS TO HAVE HIS IPG EXPLANTED AND REPLACED DUE TO NOT RECEIVING ANY PAIN RELIEF FROM HIS SCS SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281550 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3143272

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other