BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4212918 · Received October 24, 2014

    Report

    Report Number
    1627487-2014-25658
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 THE PATIENT ((B)(6)) LOST STIMULATION. X-RAYS WERE TAKEN AND REVEALED A KINK ON THE LEAD NEAR THE ANCHOR SITE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE THE LEAD WHICH RESOLVED THE ISSUE. ADDITIONALLY, IT WAS REPORTED THE PROCEDURE WAS EXTENDED BY APPROXIMATELY TWO HOURS DUE TO SCAR TISSUE AND EXCESSIVE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678885 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4157657

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other IMPLANT DATE:| SCS IPG: MODEL 3608| IMPLANT DATE:| SCS ANCHOR: MODEL 1192