BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENTA

    MDR report key: 2820181 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-02628
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    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 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-02627. IT WAS REPORTED THE PT COMPLAINED OF DISCOMFORT AT HER IPG AND LEAD SITES. SHE REPORTED THE PAIN OCCURS REGARDLESS OF WHETHER STIMULATION IS ON OR OFF. THE PHYSICIAN PRESCRIBED HER LIDOCAINE PATCHES FOR THE DISCOMFORT. THE PT ALSO REPORTED INEFFECTIVE STIMULATION COVERAGE AND REQUESTED HER SYSTEM BE REMOVED. FLUOROSCOPY REVEALED NO ANOMALIES WITH HER SCS SYSTEM. IT WAS REPORTED THE PT WAS REPROGRAMMED AND SHE WILL TRY THE NEW PROGRAM SETTINGS AND F/U WITH HER PHYSICIAN. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3121550

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SCS ANCHOR: MODEL 1192| IMPLANT DATE: