BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 1993825 · Received January 13, 2011

    Report

    Report Number
    1627487-2011-00080
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT SHE WAS UNABLE TO LOCATE HER IPG WITH THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE ALLEGED PROBLEM PERSISTS. AN APPOINTMENT HAS BEEN SCHEDULED FOR FURTHER INTERROGATION OF THE PT'S SCS SYSTEM. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILARLY REPORTED EVENTS HAVE LED TO THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3716 85047

    Patients

    Seq Age Sex Outcome Treatment
    1