BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3900080 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-15400
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    October 1, 2013
    Report Date
    May 7, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MED 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 1 OF 4. REFERENCE MFR REPORT: 1627487-2014-15401. REFERENCE MFR REPORT: 1627487-2014-15402. REFERENCE MFR REPORT: 1627487-2014-15403. THE PT HAS 2 EXTENSIONS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PT IS EXPERIENCING INTERMITTENT STIMULATION. THE PT STATED IT FELT AS IF HIS STIMULATION WAS TURNING ITSELF OFF, BUT THE PROGRAMMER INDICATED STIMULATION WAS STILL ON. THE PT ALSO EXPERIENCES OVERSTIMULATION WHEN STIMULATION IS INITIALLY TURNED ON. DIAGNOSTIC TESTING INDICATED LOW IMPEDANCE READINGS. THE PT IS TO CONSULT WITH HIS PHYSICIAN REGARDING UNDERGOING SURGICAL INTERVENTION AT THE LATER DATE AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315091 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 39835

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other