BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2881135 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-12780
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 HAD NOT CHARGED THE SYSTEM FOR AT LEAST A YR. THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A NEW CHARGER WAS SENT TO THE PT, WITH THE SAME RESULT. F/U REVEALED THE PHYSICIAN HAS SCHEDULED SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 48783

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: