BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3060205 · Received April 5, 2013

    Report

    Report Number
    1627487-2013-04416
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    July 14, 2012
    Report Date
    March 14, 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
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 1627487-07262012-002-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 HAS NOT CHARGED THE IPG IN 8 MONTHS. BOTH EXTERNAL DEVICES WOULD NOT COMMUNICATE WITH THE IPG. IT WAS REPORTED THE PHYSICIAN PLANNED TO TAKE X-RAYS. FOLLOW UP IDENTIFIED THE PHYSICIAN HAD REFERRED THE PT TO A NEUROSURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141897 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2766598

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention IMPLANTED:| SCS LEAD: MODEL 3246| SCS LEAD: MODEL 3224 (2)| IMPLANTED:| SCS EXTENSION: MODEL 3382 (2)| IMPLANTED:| SCS LEAD: MODEL 3166| IMPLANTED: