BEUDAMED
    FDA Adverse Event Death Summary report: N

    EON IPG

    MDR report key: 1883988 · Received October 21, 2010

    Report

    Report Number
    1627487-2010-03067
    Event Type
    Death
    Date Received
    October 21, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    ON (B)(6) 2010, IT WAS REPORTED THAT THE PT HAD PASSED AWAY. NO DETAILS AS TO THE CAUSE OF DEATH WERE PROVIDED AT THAT TIME. SJM MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE PT'S PHYSICIANS, BUT THOSE PHYSICIANS WERE UNAWARE THAT THE PT HAD DIED. IT WAS REPORTED ONLY THAT THE PT HAD MULTIPLE MEDICAL PROBLEMS (PER THE OBITUARY) AND HAD PASSED AWAY AT HOME ON (B)(6) 2010. NO ADDITIONAL INFO IS AVAILABLE. NO DEVICES HAVE BEEN RETURNED TO SJM FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 84107

    Patients

    Seq Age Sex Outcome Treatment
    1 Death