BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3123920 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-08120
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    IT WAS REPORTED THE PT'S IPG (IMPLANTABLE PULSE GENERATOR) WAS NOT ABLE TO ESTABLISH COMMUNICATION WITH THE EXTERNAL DEVICES THOUGH THE PT FELT THE SYSTEM WAS ON. DURING FOLLOW-UP, SJM REPRESENTATIVE CONFIRMED THE IPG WAS NOT CHARGED FOR A YEAR AND DEVICE REPLACEMENT WAS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219428 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3066212

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR IMPLANTED:| IMPLANTED:| SCS LEAD: MODEL 3166| SCS LEAD: MODEL 3186