BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2080206 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01370
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    July 1, 2010
    Report Date
    March 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, INCLUDING AN IPG, ON (B)(6) 2006. IT WAS REPORTED THAT THE PATIENT HAS BEEN WITHOUT STIMULATION FOR AT LEAST EIGHT MONTHS. THE PATIENT PROGRAMMER AND CHARGER WERE UNABLE TO COMMUNICATE WITH THE IPG. A REPLACEMENT CHARGING SYSTEM WAS UNSUCCESSFUL AT RESOLVING THE ISSUE. FOLLOW UP ON THE PATIENT FOUND THAT THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE IPG. A SURGERY DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 55568

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention