BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2903007 · Received December 26, 2012

    Report

    Report Number
    1627487-2012-11906
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-11905. IT WAS REPORTED THE CHARGING SYSTEM WAS GETTING HOT AFTER 20 MINS OF USE. A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PT. F/U WITH THE PT FOUND THE REPLACEMENT CHARGER WAS WORKING WELL, AND THE PT REPORTED SHE WAS SATISFIED WITH THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3831934

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| SCS EXTENSION: MODEL 3386 (2)