BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2821117 · Received October 25, 2012

    Report

    Report Number
    1627487-2012-12377
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 4, 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 HOSPITALIZED WITH RESPIRATORY FAILURE TWO DAYS AFTER THE IMPLANT SURGERY. THE PHYSICIAN¿S ASSISTANT DID NOT BELIEVE THE EVENT WAS RELATED TO THE SCS SYSTEM. FOLLOW UP DETERMINED THE PT HAS RECOVERED AND HAS OPTIMAL PAIN COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3629664

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R IMPLANT DATE:| SCS IPG: MODEL 3788