BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3042315 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-02466
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 PATIENT HAD NOT USED OR CHARGED HER SCS SYSTEM IN APPROXIMATELY 2 YEARS. IT WAS REPORTED HER IPG WAS NO LONGER ABLE TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. FOLLOW-UP IDENTIFIED THE DEVICE WAS EXPLANTED ON (B)(6) 2013. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138502 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2844883

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR IMPLANTE DATE:| SCS LEAD: MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)