BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD, 3/6MM, 30 CM

    MDR report key: 4950898 · Received July 29, 2015

    Report

    Report Number
    1627487-2015-26345
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 #1 OF 2: REFERENCE MFR. REPORT: 1627487-2015-26346 IT WAS REPORTED THE PATIENT WAS EXPERIENCING AUTO-REDUCING AND HIGH IMPEDANCES ON MULTIPLE CONTACTS. THE PATIENT IS REQUESTING A REVISION TO ATTAIN LEFT SIDED COVERAGE. SURGICAL INTERVENTION MAY BE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492702 QUATTRODE LEAD, 3/6MM, 30 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3153 4524760

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other MODEL 1194(2), SCS ANCHOR| MODEL 3343, SCS EXTENSION