BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2881393 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-13235
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 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 WAS NOT RECEIVING EFFECTIVE THERAPY FROM HER SCS SYSTEM. A SJM REP MET WITH THE PT AND REPROGRAMMED HER SCS SYSTEM. HE WASN'T ABLE TO IMPROVE HER DESIRED PAIN COVERAGE. THE PT'S PHYSICIAN STATED SHE WOULD LIKE TO MANAGE HER PT'S EXTRA PAIN THROUGH HER PAIN PUMP. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3121550

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: