BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3123598 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-03661
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 3. REFERENCE MFR REPORTS: 1627487-2013-03660 AND 1627487-2013-03662. THE PT HAS 2 MODEL 3166 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT'S SCS SYSTEM WAS REPLACED DUE TO THE PT NO LONGER RECEIVING EFFECTIVE STIMULATION AFTER BECOMING DESENSITIZED TO THE THERAPY. IT WAS ALSO REPORTED THE ISSUE RESOLVED WITH THE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219278 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3783020

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED:| SCS EXTENSION: MODEL 3346 (2)