BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3821001 · Received May 8, 2014

    Report

    Report Number
    1627487-2014-03322
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 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 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 1 OF 3. REFERENCE MFR REPORTS: 1627487-2014-03323 AND 1627487-2014-03324. IT WAS REPORTED THE PT EXPERIENCED INEFFECTIVE STIMULATION FOLLOWING AN ELECTROMYOGRAM. DIAGNOSTICS SHOWED LOW IMPEDANCE VALUES. AN SJM REPRESENTATIVE WAS UNABLE TO RESOLVE THE ISSUE WITH REPROGRAMMING. FOLLOW-UP IDENTIFIED X-RAYS REVEALED NO ANOMALIES WITH THE LEADS OR SCS IPG. THE PHYSICIAN HAS DECIDED SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279684 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3389149

    Patients

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