BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2993980 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10064
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 5, 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
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. THIS IPG SERIAL NUMBER WAS ALSO INCLUDED IN A FIELD CORRECTION. RECALL NUMBERS: 1627487-12192011-003-R, 1627487-07262012-002-R, 1627487-07262012-001-C. RESULTS: THE COMPLAINT REGARDING POCKET HEATING WHILE RECHARGING WAS CONFIRMED. EXTENSIVE INVESTIGATION FOR THIS COMPLAINT HAS FOUND THE IPG CAN GENERATE EXCESSIVE HEATING WHEN RECHARGED WITH THE 3721 CHARGING SYSTEM. THIS INVESTIGATION WAS ADDRESSED IN THE POCKET HEATING CAPA. NO IPG FAILURES OBSERVED. 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: 1627487-2013-10065. IT WAS REPORTED THE PATIENT (SPAIN) EXPERIENCED DISCOMFORT WHILE CHARGING THE IPG. THE PATIENT REPORTED SHE DEVELOPED BRUISES AND LESIONS ON THE SKIN SURROUNDING THE IPG SITE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE IPG UPON EXPLANT, THE PHYSICIAN NOTED THAT THE IPG POCKET WAS AFFECTED BY BURNS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89446 EON MINI SCS IPG LGW ST. JUDE MEDICAL NEUROMODULATION 3788 3301985

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention