BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3961135 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-26562
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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

    THE PATIENT UNDERWENT A PROCEDURE FOR A PERMANENT SCS SYSTEM ON (B)(6) 2014. THE FOLLOWING DAY THE PATIENT WENT TO THE EMERGENCY ROOM WITH A COMPLAINT OF ABDOMINAL PAIN ABOVE THE BELLY BUTTON. A CT SCAN WAS TAKEN AND THE PATIENT WAS PRESCRIBED STEROIDS. POSTOPERATIVELY THE PATIENT WAS PROGRAMMED AND THERE WAS NO COMPLAINT OF ABDOMINAL PAIN. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT WAS EXPLANTED ON (B)(6) 2014 BECAUSE THE ABDOMINAL PAIN WAS NOT SUBSIDING. POSTOPERATIVELY THE ABDOMINAL PAIN IS GONE AND ONLY THE POST SURGICAL DISCOMFORT IS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413378 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4562658

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization SCS IPG: MODEL 3788| IMPLANT DATE: