BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012226 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-06046
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBERS: 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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: 1627487-2013-06047. IT WAS REPORTED THE PT WAS EXPERIENCING POCKET HEATING WHILE CHARGING. THE PT THEN STOPPED CHARGING AND USING HER SYSTEM, BUT DID NOT INFORM ANYONE AT THE TIME. THE IPG IS BELIEVED TO THE PAST THE POINT OF RECHARGE DUE TO THE PROLONGED PERIOD WITHOUT RECHARGING. THE PT WAS REQUESTED TO HAVE HER IPG REPLACED WITH A NON-RECHARGEABLE IPG. FOLLOW-UP INDICATES THE PT HAD HER RECHARGEABLE IPG REPLACED ON (B)(6) 2013 WITH A NON-RECHARGEABLE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104574 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 174281

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SCS LEAD: MODEL 3186 (X2)| IMPLANT DATE: