BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3142217 · Received May 29, 2013

    Report

    Report Number
    1627487-2013-01592
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-1593. IT WAS REPORTED THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED MULTIPLE INVALID CONTACTS. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT'S ENTIRE SCS SYSTEM WAS REMOVED AND REPLACED WITH A DIFFERENT MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237305 QUATTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3146 39832

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: