BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2992308 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-05298
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 3 OF 4. REFERENCE MFR. REPORT#: 1627487-2013-05296, 1627487-2013-05297, 1627487-2013-05299. THE PATIENT HAS FOUR LEADS (TWO ARE FROM THE SAME LOT) AND AN IPG FOR OFF-LABEL USE. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING ADEQUATE COVERAGE. IT WAS ALSO REPORTED THE PATIENT IS EXPERIENCING PAIN AND ITCHING AT THE IPG AND LEAD SITE. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89124 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3163 3258350

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT:| IMPLANT:| SCS EXTENSIONS, MODEL: 3341 (X2)| SCS ANCHORS, MODEL: 1192 (X4)