BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-8

    MDR report key: 2921778 · Received January 14, 2013

    Report

    Report Number
    1627487-2013-02094
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 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 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

    DEVICE 3 OF 3. REFERENCE MFR REPORTS: 1627487-2013-02092 AND 1627487-2013-02093. IT WAS REPORTED THE PT'S IPG WAS "PUSHING THROUGH THE SKIN". THE PT ALSO REPORTED HE FELT A SHOCKING SENSATION OCCASIONALLY AND HIS SCS SYSTEM DID NOT PROVIDE EFFECTIVE STIMULATION COVERAGE. IT WAS REPORTED THE PT REFUSES TO BE REPROGRAMMED AND WOULD LIKE HIS SYSTEM REMOVED. ALLEGEDLY, THE PT PLANS TO SCHEDULE A CONSULT WITH HIS PHYSICIAN REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20907 S-8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3190283

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)