BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2820115 · Received November 2, 2012

    Report

    Report Number
    1627487-2012-01979
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. RESULTS: THE COMPLAINT WAS NOT CONFIRMED. AS RECEIVED, THE IPG WAS IN GOOD CONDITION. MICROSCOPIC INSPECTION DID NOT REVEAL ANY ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT. THE IPG WAS TESTED TO MANUFACTURING SPECIFICATIONS USING THE AUTOTESTER. THE IPG PASSED ALL TESTS ON THE AUTOTESTER. 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 2 OF 3. REFERENCE MFR REPORT: 1627487-2012-01978, REFERENCE MFR REPORT: 1627487-2012-01980. THE PT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION AND WAS EXPERIENCING A BURNING SENSATION AT HER IPG SITE WHILE CHARGING. THE PT'S SCS SYSTEM WAS REPLACED WITH A NEW ONE. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION AND IS NO LONGER EXPERIENCING BURNING ISSUES. ON (B)(4) 2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. 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
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2880030

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL: 1194 (2)