BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 5718791 · Received June 10, 2016

    Report

    Report Number
    1627487-2016-03039
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 20, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 3 OF 3: REFERENCE MFR. REPORTS:1627487-2016-03037 & 1627487-2016-03038. THE PATIENT HAD 4 SCS LEADS. TWO OF THE LEADS WERE FROM THE SAME LOT (3234056). IT WAS REPORTED THE PATIENT WAS RECEIVING INEFFECTIVE STIMULATION. AS A RESULT, THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373387 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 3234056

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other