BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4112898 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-24200
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 15, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2014-24199. IT WAS REPORTED THE PT HAS NOT USED OR CHARGED BOTH HER IPGS FOR AN EXTENDED PERIOD OF TIME AND IS WITHOUT STIMULATION. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND INDICATED NEITHER IPG WAS ABLE TO COMMUNICATE WITH EXTERNAL DEVICES. ADDITIONALLY A COMMUNICATION ERROR MESSAGE WAS DISPLAYED. SURGICAL INTERVENTION TOOK PLACE TO EXPLANT AND REPLACE BOTH HER THORACIC AND CERVICAL IPGS. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576051 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 176441

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANTED:| SCS LEAD: MODEL 3186 (2)