BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3909177 · Received June 11, 2014

    Report

    Report Number
    1627487-2014-23395
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    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 3 OF 3. REFERENCE MFR REPORT #: 1627487-2014-23393; 1627487-2014-233954. IT WAS REPORTED, THE PATIENT EXPERIENCED AUTO-REDUCING. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. DIAGNOSTIC TESTING REVEALED MULTIPLE INVALID AND LOW IMPEDANCE READINGS. FOLLOW-UP INFORMATION REVEALED THE PATIENT WILL UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346194 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 3360811

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)