BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3010523 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-04330
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 2 OF 2. REFERENCE MFR REPORT # 1627487-2013-04329. IT WAS REPORTED THE PT HAD EFFECTIVE STIMULATION, BUT WANTED MORE COVERAGE. THE PT HAD THREE LEADS, AND TWO WITH THE SAME LOT NUMBER. IT WAS REPORTED TWO OF THE LEADS WERE PERIPHERAL LEADS (OFF-LABEL USE). THE PHYSICIAN DECIDED TO REPLACE THE LEADS WITH ONE SURGICAL LEAD TO PROVIDE MORE COVERAGE. FOLLOW UP IDENTIFIED THE PHYSICIAN REPLACED THE LEADS WITH ONE SURGICAL LEAD. IT WAS REPORTED THE PT REC'D EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108278 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3166 3218964

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SCS EXTENSION: MODEL 3341| SCS IPG: MODEL 3688| IMPLANT DATE:| IMPLANT DATE,