BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 1961070 · Received January 12, 2011

    Report

    Report Number
    1627487-2011-00061
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    DEVICE 1 OF 3. REFERENCE MFR. REPORT # 1627487-2011-00062 AND 1627487-2011-00063. THE PT ((B)(6)) RECEIVED AN SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, SURGICAL LEAD AND EXTENSION. IT WAS REPORTED THAT THE PT LOST STIMULATION. DURING THE SURGICAL PROCEDURE TO CORRECT THE PROBLEM, IT WAS OBSERVED THAT THE EXTENSION WAS BROKEN AND DISCONNECTED FROM THE IPG HEADER. IN ADDITION, INTRAOPERATIVE TESTING ON THE SURGICAL LEAD REVEALED HIGH IMPEDANCE READINGS ON ALL CONTACTS. AS A RESULT OF THESE FINDINGS, THE PT'S SCS SYSTEM WAS REPLACED. THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 2884534

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention