BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2861031 · Received December 3, 2012

    Report

    Report Number
    1627487-2012-13152
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER - 1627487-12192011-003-R, 1627487-07262012-001-C. 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: 1627487-2012-13153. IT WAS REPORTED THE PT EXPERIENCED CONSTANT POCKET HEATING AT HIS IPG SITE. HE STATED THE HEATING IS MORE INTENSE WHEN HE CHARGES THE IPG. A SJM REP MADE SOME RECOMMENDATIONS ON CHARGING TECHNIQUE AND A REPLACEMENT CHARGER WAS SENT TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2887049

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3228