BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 6156688 · Received December 8, 2016

    Report

    Report Number
    1627487-2016-06343
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 16, 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).

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2016-06342. IT WAS REPORTED ONE OF THE PATIENT OCCIPITAL (OFF LABEL) LEADS HAD MIGRATED. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2016 AT WHICH THE LEADS WAS REPOSITIONED. THE PATIENT REPORTED EFFECTIVE STIMULATION FOLLOWING THE PROCEDURE AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804389 QUATTRODE LEAD WIDE SPACED, 60 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3166 5415126

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other MODEL 3169 (2), SCS LEAD| MODEL 3341 (2), SCS EXTENSION| MODEL 3788, SCS IPG