BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2140947 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-03111
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 A SCS SYSTEM ALONG WITH SURGICAL LEAD ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S IPG WAS EXPLANTED DUE TO CHARGER COMMUNICATION ISSUES. THE PT SAW LOW BATTERY WARNING. THE SJM REP CHECKED IMPEDANCES ON SEVERAL CONTACTS, BUT THEY WERE FOUND TO BE NORMAL. REVISION WAS SCHEDULED ON (B)(6) 2011. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTAL IMPLANTATION PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2880146

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention SCS LEAD: MODEL 3219| IMPLANTED: