BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4091939 · Received August 27, 2014

    Report

    Report Number
    1627487-2014-26680
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-7262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. 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

    IT WAS REPORTED THE PT WAS UNABLE TO COMMUNICATE HER IPG WITH ANY EXTERNAL DEVICES. THE SJM REPRESENTATIVE CONFIRMED THE ISSUE. THE PT REPORTS SHE DID NOT RECHARGE HER IPG FOR 2-3 MONTHS. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522597 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3504452

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other SCS LEAD, MODEL 3228| IMPLANT DATE: