BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2230828 · Received August 23, 2011

    Report

    Report Number
    1627487-2011-06066
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S IPG WAS REPLACED ON (B)(6) 2011 IN AN EFFORT TO RESOLVE A PREVIOUSLY REPORTED IMPEDANCE ISSUE. DURING THE PROCEDURE, A NICK WAS OBSERVED ON THE PT'S LEAD. (REFERENCE MFR. REPORT # 1627487-2011-00762 FOR LEAD REPORT). THE EXPLANTED IPG WAS 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 3788 3166007

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS LEAD: MODE: 3228| IMPLANT DATE: