BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE

    MDR report key: 2891639 · Received December 7, 2012

    Report

    Report Number
    1627487-2012-03809
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2012-03808. THE PT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. THE PT REPORTED SHE STOPPED USING HER SCS SYSTEM FOR APPROX A YEAR AND WOULD LIKE HER SCS SYSTEM EXPLANTED DUE TO NOT RECEIVING EFFECTIVE STIMULATION IN THE NEEDED AREA. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3179689

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR SCS IPG: MODEL 3688| IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3341 (2)