BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4151867 · Received October 6, 2014

    Report

    Report Number
    1627487-2014-24248
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ST JUDE MED 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

    THE PT HAS 2 LEADS FROM THE SAME LOT IMPLANTED AS PART OF HER SYSTEM. IT WAS REPORTED THAT THE PT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTIC TESTING INDICATED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE COVERAGE. SURGICAL INTERVENTION WAS UNDERTAKEN AND ONE LEAD WAS FOUND TO BE FRACTURED AND ONE LEAD WAS SHEARED. BOTH LEADS WERE EXPLANTED AND REPLACED. FURTHER DIAGNOSTICS TESTING INDICATED IMPEDANCE WITHIN NORMAL LIMITS. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623246 OCTRODE SCS LEAD GZB ST JUDE MED NEUROMODULATION 3186 3965256

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2),