BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2892894 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-02923
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 6, 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 INFORMATION 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 COMPLAINED OF NAUSEA AND ABDOMINAL PAIN/TIGHTNESS. THE PT HAD GI AND ORTHOPEDIC CONSULTATIONS REGARDING THE ISSUE AND WAS ADVISED TO LEAVE STIMULATION OFF. HIS ABDOMINAL PAIN ALLEGEDLY PERSISTED WHEN STIMULATION WAS OFF AND HIS NAUSEA WAS TREATED WITH SCOPOLAMINE. FOLLOW-UP IDENTIFIED THE PT'S SYSTEM WAS REMOVED DUE TO THE ISSUE. IT WAS REPORTED THE ABDOMINAL PAIN HAD NOT RESOLVED POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3752837

    Patients

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