BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3950309 · Received June 19, 2014

    Report

    Report Number
    1627487-2014-01395
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 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 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

    DEVICE 1 OF 2. REFER TO MFR REPORT # 1627487-2014-01396. IT WAS REPORTED THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2014 EXPLANTING AND REPLACING ONE LEAD IN AN EFFORT TO OBTAIN ADDITIONAL LEFT-SIDED COVERAGE. THE PHYSICIAN ELECTIVELY REPLACED THE ORIGINAL IPG DURING THE SAME PROCEDURE. BOTH LEADS ARE BEING REPORTED AS IT IS UNCERTAIN WHICH LEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360871 OCTRODE SCS LEAD GZB ST JUDE MEDICAL NEUROMODULATION 3186 3995750

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR IMPLANT DATE:| SCS IPG: MODEL 3788,