BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2831915 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-11653
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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: 1627487-2012-11654. IT WAS REPORTED THE PATIENT HAD RECEIVED THE CHARGING LETTER FROM SJM, AND WANTED TO UNDERSTAND THE LETTER. THE PATIENT REPORTED SHE HAD HER SCS SYSTEM EXPLANTED SHORTLY AFTER THE IMPLANT OF THE SYSTEM. THE PATIENT REPORTED SHE HAD TO HAVE ANOTHER PROCEDURE PERFORMED, AND SHE DID NOT THINK THE SYSTEM WAS EFFECTIVE. THE PATIENT WAS UNABLE TO PROVIDE THE EXPLANT DATE. THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. ON (B)(4) 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
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 174138

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention