BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3193622 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-13973
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    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
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-12192011-003-R AND 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY AND FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-13974. THE PATIENT REPORTED HE EXPERIENCED POCKET HEATING WHILE CHARGING HIS IPG. THE PATIENT'S PHYSICIAN DID OBSERVE SOME REDNESS AT THE IPG SITE. THE PATIENT WAS INSTRUCTED TO REDUCE HIS CHARGING TIME FROM 90 MINUTES TO 30 MINUTE INTERVALS. A NEW LE CHARGER WAS SENT TO THE PATIENT. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288432 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2839208

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1194 (2)| IMPLANT:| IMPLANT: