BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3001454 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-01257
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    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 ONE OF THE PT'S LEADS SHOWED INVALID IMPEDANCES DURING A TRIAL PROCEDURE. IT WAS NOTED THE LEAD APPEARED TO BE FINE INITIALLY BUT MAY HAVE BEEN DAMAGED DUE TO THE FORCE USED DURING INSERTION. THE LEAD WAS REMOVED AND DISCARDED. THE NECESSARY COVERAGE WAS ACHIEVED WITH ONLY ONE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93583 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3428641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention