BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831860 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-00744
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2012-00745. IT WAS REPORTED THE PATIENT ((B)(6)) LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. THE PATIENT'S IPG WAS REPORTEDLY FUNCTIONING; HOWEVER, THE BATTERY STATUS FOR THE DEVICE WAS LOW. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PATIENT'S LEAD AND IPG. THE LEAD WAS CUT DURING EXPLANT DUE TO EXCESS SCAR TISSUE AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention