BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 30 CM

    MDR report key: 4760605 · Received May 8, 2015

    Report

    Report Number
    1627487-2015-23266
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    January 20, 2015
    Report Date
    July 1, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD BE PMA/510(K) # K072462 NOT PMA/510(K) # P0100032 AS PREVIOUSLY REPORTED. EVALUATION: RESULTS: REPORTED COMPLAINT OF INEFFECTIVE STIMULATION WAS CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION ON THE QUATTRODE LEAD REVEALED BREAKAGE WITH ALL WIRES BROKEN. THIS DAMAGE IS CONSISTENT WITH REPETITIVE OVERSTRESS CAUSED WHILE THE LEAD WAS IN THE PATIENT BODY. 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.

    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

    IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION COVERAGE IN HER BACK. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCE READINGS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2015, WHERE THE PATIENT'S LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304663 QUATTRODE LEAD WIDE SPACED, 30 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3860318

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other MODEL 3186, SCS LEAD| MODEL 3788, SCS IPG