BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4112907 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-08278
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 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

    THE PATIENT HAD TWO MODEL 3186 LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT'S SCS LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2014 DUE TO POSSIBLE LEAD MIGRATION AND INADEQUATE COVERAGE. THE PATIENT IS REPORTEDLY RECEIVING EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577222 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3772975

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other SCS IPG, MODEL: 3788| SCS ANCHOR, MODEL: 1192| IMPLANT DATE:| IMPLANT DATE: