BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3031972 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-15411
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATIO
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15412. IT WAS REPORTED THE PT EXPERIENCE HEATING WHILE CHARGING HER IPG. THE SJM REP REVIEWED THE CHARGING GUIDELINES WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128653 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATIO 3716 117082

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3214| SCS EXTENSION: MODEL 3383