BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3820873 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-23309
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 21, 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
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 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

    THE PT REPORTED, SHE IS UNABLE TO ESTABLISH COMMUNICATION BETWEEN HER IPG AND CHARGER. IT WAS ALSO REPORTED, THE PT IS WITHOUT STIMULATION. THE PT REPORTED, SHE HAS NOT CHARGED THE IPG IN 9 MONTHS AS SHE HAS BEEN PREGNANT. THE PT WAS SENT A REPLACEMENT CHARGER, WHICH DID NOT RESOLVE THE ISSUE. IN ADDITION, THE PT'S PROGRAMMER DISPLAYS A COMMUNICATION ERROR. THE PT WILL CONSULT WITH THE PHYSICIAN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286868 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2834055

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other IMPLANT DATE:| SCS EXTENSION: MODEL 3383| SCS LEAD: MODEL 3286| IMPLANT DATE: