BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2792247 · Received October 10, 2012

    Report

    Report Number
    1627487-2012-11464
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 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
    NY, 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: 1627487-2012-11465. IT WAS REPORTED, THE PT WAS EXPERIENCING HEATING AT THE IPG SITE AFTER 10 MINS OF CHARGING THE IPG. IT WAS REPORTED, THE PT WAS SCHEDULED FOR AN APPOINTMENT REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2872643

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1194 (2)