BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3820878 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-26400
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 HAS BEEN EXPERIENCING AUTO-REDUCING SINCE APPROX (B)(6) 2014 (EXACT DATE UNK). THE PT EXPERIENCES PAIN IN BOTH LEGS BUT RECEIVES STIMULATION ONLY IN THE LEFT LEG. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286624 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3768683

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: