BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141429 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-13803
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    March 3, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. THE COMPLAINT WAS CONFIRMED: AS RECEIVED THE IPG WAS NON-RESPONSIVE. THE REPORTED COMPLAINT CANNOT BE ANALYZED AS THIS IS CONSIDERED TO BE A USER ERROR. 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 REPORTED SHE HAD NOT CHARGED HER IPG FOR OVER 3 MONTHS AND IT IS MOT LIKELY DEPLETED. FOLLOW-UP INFO IDENTIFIED THE PT'S IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2013. THE PT WAS RECEIVING EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231984 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 171787

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD: MODEL 3280| IMPLANTED: