BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR

    MDR report key: 3963699 · Received May 22, 2014

    Report

    Report Number
    1627487-2014-25401
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    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 2 REFERENCE MFR. REPORT# 1627487-2014-25191.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304242 ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 3083967

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR SCS IPG: MODEL 3788| IMPLANT DATE: