BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI

    MDR report key: 3113294 · Received May 3, 2013

    Report

    Report Number
    1627487-2013-04521
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-04522. IT WAS REPORTED THE PT WAS UNABLE TO LOCATE THE IPG WITH THE CHARGING SYSTEM SO A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. DURING FOLLOW UP, THE PT REPORTED SHE HAD NOT USED THE SCS SYSTEM FOR A YEAR. THE PT REPORTED THE LEAD HAD MIGRATED, AND THE STIMULATION WAS NOT NEEDED. IT WAS UNDETERMINED IF THE PT HAD NOT CHARGED THE IPG DURING THIS TIME. ATTEMPTS TO CONTACT THE PT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193535 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3504445

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL: 1194