BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2033584 · Received February 11, 2011

    Report

    Report Number
    1627487-2011-01134
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    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 AND TWO SURGICAL LEADS, ON (B)(6) 2009. IT WAS REPORTED THAT THE IPG WAS UNABLE TO COMMUNICATE WITH THE CHARGER OR PATIENT PROGRAMMER. THE PATIENT STATED THAT HE FELT THAT THE IPG HAD MOVED AT THE POCKET SITE. IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING COMMUNICATION PROBLEMS WITH THE PROGRAMMER OVER TWO MONTHS PRIOR, AND SEVERAL WEEKS LATER, HE LOST STIMULATION. A REPLACEMENT CHARGER WAS UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PATIENT HAD NOT YET RESCHEDULED A FOLLOW UP APPOINTMENT FOR REPROGRAMMING. 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 175548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention