BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE TRIAL LEAD KIT, 60CM LENGTH

    MDR report key: 6207926 · Received December 27, 2016

    Report

    Report Number
    1627487-2016-06609
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    December 6, 2016
    Report Date
    January 6, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER¿S EVALUATION: THE COMPLAINT OF INFECTION CANNOT BE CONFIRMED VIA LABORATORY TESTING. 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2016-06608. FOLLOW-UP IDENTIFIED THE PATIENT'S INFECTION HAS RESOLVED.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2016-06608. IT WAS REPORTED THE PATIENT HAD HER TRAIL LEADS REMOVED ON (B)(6) 2016 DUE TO A SUSPECTED INFECTION. THE PATIENT EXPERIENCED REDNESS AND BURNING AT THE LEAD INSERTION SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855204 OCTRODE TRIAL LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 5668347

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other