BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG

    MDR report key: 1942128 · Received November 12, 2010

    Report

    Report Number
    1627487-2010-03250
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 REC'D HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2010 THAT THE PT LOST HER CHARGING SYSTEM AND HAS BEEN W/O STIMULATION FOR A MONTH. IN AN EFFORT TO RESOLVE THIS MATTER, A REPLACEMENT CHARGING SYSTEM WAS SHIPPED TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME AS ALL ATTEMPTS TO CONFIRM RESOLUTION HAVE BEEN UNSUCCESSFUL. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS THIS EVENT COULD LEAD TO THE EXPLANT OF THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 172207

    Patients

    Seq Age Sex Outcome Treatment
    1