BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4212826 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-06304
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ST JUDE MED - 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 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 IS NOT RECEIVING EFFECTIVE STIMULATION. AN SJM REP MET WITH THE PT AND LEAD DIAGNOSTICS SHOWED MULTIPLE INVALID CONTACTS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT IS WORKING WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678087 PENTA SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3228 4094171

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other SCS ANCHOR, MODEL 1192| IMPLANT DATE:| SCS IPG, MODEL 3788| IMPLANT DATE: