BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2093165 · Received April 14, 2011

    Report

    Report Number
    1627487-2011-01382
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 REC'D HER SCS SYS, INCLUDING AN IPG, ON (B)(6) 2007. IT WAS REPORTED THAT THE PT'S IPG WAS UNABLE TO COMMUNICATE WITH THE CHARGER OR PROGRAMMER. TH PT REPORTED THAT SHE LAST CHARGED IN LATE (B)(6) 2010, AND SHE HAS NOT HAD STIMULATION SINCE THE BEGINNING OF (B)(6) 2010. IT WAS REPORTED THAT A REPLACEMENT CHARGER AND PROGRAMMER WILL BE TRIED. THE PT PLANNED TO SCHEDULE AN APPOINTMENT WITH HER PHYSICIAN ABOUT THE NEXT COURSE OF ACTION. NO FURTHER INFO 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 2770533

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention