BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961137 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-03470
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ST.JUDE MEDICAL - NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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

    IT WAS REPORTED DURING THE PATIENT'S IPG REPLACEMENT PROCEDURE (REFERENCE MFR. REPORT: 1627487-2014-05488), INTRA-OPERATIVE DIAGNOSTICS REVEALED INVALID IMPEDANCE VALUES FOR THE SCS LEAD. AS A RESULT, THE SCS LEAD WAS EXPLANTED AND REPLACED. ALSO, THE PHYSICIAN DECIDED TO ADD AN ADDITIONAL LEAD. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION FOLLOWING THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413188 OCTRODE SCS LEAD GZB ST.JUDE MEDICAL - NEUROMODULATION SYSTEMS 3186 172366

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other IMPLANT DATE:| SCS IPG: MODEL 3608