BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5533497 · Received March 29, 2016

    Report

    Report Number
    1627487-2016-01594
    Event Type
    Injury
    Date Received
    March 29, 2016
    Report Date
    May 23, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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#: 1627487-2016-01595. THE PATIENT ((B)(6)) WAS IMPLANTED WITH TWO LEADS FROM THE SAME LOT NUMBER 4990830. IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION IN UNDESIRED AREAS. LEAD DIAGNOSTIC TESTING REVEALED NORMAL IMPEDANCE MEASUREMENTS. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE LEADS WHICH RESOLVED THE ISSUE. ALL KNOWN LEADS HAVE BEEN REPORTED FOR THE PATIENT SINCE IT IS UNKNOWN WHAT LEADS WERE IMPLANTED.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2016-01595.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188337 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4990830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other