BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3082276 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-12500
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 3. REFERENCE MFR REPORT #1627487-2013-12499 AND 12501. IT WAS REPORTED THE PHYSICIAN REMOVED AND REPLACED THE IPG AND LEADS DUE TO SYSTEM NO LONGER WORKING. NOTE THE PATIENT RECEIVED TWO LEADS FROM DIFFERENT LOT NUMBERS. BOTH LEADS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164148 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3156 19137

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention