BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/4MM, 60 CM

    MDR report key: 6293053 · Received February 1, 2017

    Report

    Report Number
    1627487-2017-00527
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 13, 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

    (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 #2 OF 2: REFERENCE MFR. REPORT: 16271487-2017-000526. THE PATIENT IS IMPLANTED WITH TWO LEADS (MODEL 3146) FROM THE SAME LOT. T WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION THUS THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 201 WHERE THE THORACIC LEADS WERE REMOVED AND REPLACED WITH CERVICAL LEADS. THE PATIENT IS RECEIVING EFFECTIVE STIMULATION AND THE ISSUE HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77983 QUATTRODE LEAD, 3/4MM, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 4073554

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other MODEL 1192 (3), SCS ANCHOR| MODEL 3341, SCS EXTENSION| MODEL 3788, SCS IPG