BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4201971 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-25649
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 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

    RESULTS: IT WAS FOUND THAT THE RETURNED LEAD HAD A KINK IN THE OUTER TUBING WITH ALL INTERNAL WIRES BROKEN. IT WAS CONCLUDED THAT THE FRACTURE IN THE LEAD WAS CONSISTENT WITH STRESS THE LEAD WAS SUBJECTED TO AT THE DISTAL END OF THE SWIFT-LOCK ANCHOR. 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 PT (B)(6) LOST STIMULATION. IN TURN, THE PT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE THE PHYSICIAN NOTED ONE OF THE PT'S TRIAL LEADS APPEARED TO HAVE AN IMPRESSION ON THE OUTER INSULATION AND THE LEAD WAS NO LONGER NEEDED. AS A RESULT, THE PHYSICIAN EXPLANTED THE TRIAL LEAD WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663378 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4075000

    Patients

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