BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202462 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-15773
    Event Type
    Injury
    Date Received
    October 21, 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
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT#: 1627487-2014-15774. IT WAS REPORTED THE PATIENT HAD NOT USED STIMULATION IN APPROXIMATELY 4 MONTHS DUE TO UNDERGOING TREATMENT FOR AN UNRELATED MEDICAL CONDITION. THE PATIENT ATTEMPTED TO USE STIMULATION, HOWEVER THE SYSTEM WAS AUTO-REDUCING. DIAGNOSTIC TESTING INDICATED HIGH IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE PATIENT'S SCS SYSTEM WAS EXPLANTED AND REPLACED. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669103 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 55678

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other IMPLANT:| SCS IPG: MODEL 3716