BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3926158 · Received June 2, 2014

    Report

    Report Number
    1627487-2014-02391
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 8, 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

    IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION THERAPY FROM HER SCS SYSTEM. REPROGRAMMING DID NOT RESOLVE THE ISSUE. THE PT IS PENDING A CONSULTATION WITH HER PAIN MANAGEMENT PHYSICIAN TO FURTHER EVALUATE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320914 PENTA SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3228 3903752

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (X2)