BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2042058 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-00446
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00447 AND 1627487-2011-00448. THE PATIENT RECEIVED AN SCS SYSTEM ON (B)(6) 2009 INCLUDING AN IPG, TWO SURGICAL LEADS AND TWO LEAD EXTENSIONS. THE ORIGINAL LEAD WAS REPLACED ON (B)(6) 2010 DUE TO IMPEDANCE ISSUES (REFERENCE MFR REPORT # 1627487-2010-00266). IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS. EFFORTS TO RECAPTURE EFFECTIVE STIMULATION VIA REPROGRAMMING WERE UNSUCCESSFUL. THE PATIENT'S ENTIRE SCS SYSTEM WAS EXPLANTED AT HER REQUEST.

    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 2857269

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention