BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 1934106 · Received December 8, 2010

    Report

    Report Number
    1627487-2010-03406
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. THE PATIENT TURNED OFF HIS STIMULATION WHILE OUT OF TOWN. TWO WEEKS LATER, HE WAS UNABLE TO TURN THE STIMULATION BACK ON. HIS IPG WAS UNABLE TO COMMUNICATE WITH HIS PATIENT PROGRAMMER AND HIS CHARGER, AND EXTERNAL REPLACEMENT DEVICES HAVE BEEN UNSUCCESSFUL IN COMMUNICATING WITH THE IPG. AN X-RAY SHOWED THAT THE LEAD AND IPG APPEARED INTACT. THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE IPG ON (B)(6) 2010. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3788 2884612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention