BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2113698 · Received June 2, 2011

    Report

    Report Number
    1627487-2011-00751
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT PERSONNEL OF THE MFR WAS AWARE OF THIS EVENT A FEW DAYS AFTER ITS OCCURRENCE. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00752. THE PT WAS IMPLANTED WITH TWO SCS SYSTEMS. THE FIRST ON (B)(6) 2007 AND THE SECOND ON (B)(6) 2008. IT WAS REPORTED THAT BOTH IPGS WERE REPLACED WITH DEVICES FROM A COMPETING MFR. THE PT'S EXISTING LEADS WERE CONNECTED TO THE NEW IPGS. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY. NO FURTHER INFO IS AVAILABLE.

    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 3716 85479

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS LEAD ANCHOR: 1194| IMPLANTED:| SCS LEAD: MODEL 3186| IMPLANTED:| SCS LEAD: MODEL 3189| IMPLANTED: