BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2201488 · Received August 3, 2011

    Report

    Report Number
    1627487-2011-07015
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 PT RECEIVED AN SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT IS FEELING STIMULATION AND AT TIMES, SHE IS ABLE TO LOCATE THE IPG TO CHARGE, BUT AFTER A FEW MINUTES, THE CHARGER GETS VERY HOT AND NO LONGER LOCATES THE IPG. THE DEVICE WAS NOT DROPPED NOR EXPOSED TO ELEMENTS. A REPLACEMENT CHARGER WAS SENT TO THE PT AND DETERMINED IT IS ALSO UNABLE TO LOCATE THE IPG. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16 - CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3716 86254

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS LEAD: MODEL 3214| IMPLANT: