BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENPULSE

    MDR report key: 2183321 · Received July 28, 2011

    Report

    Report Number
    6000144-2011-03560
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    April 5, 2005
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S032
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED NO ANOMALIES FOUND. (B)(4) THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED NO ANOMALIES FOUND. EVALUATION SUMMARY: (B)(4) PROXIMAL SEGMENT; (B)(4) PROXIMAL SEGMENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED NO ANOMALIES FOUND. (B)(4) HE PROXIMAL SEGMENT WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH NO INFORMATION. A SEARCH BY SERIAL NUMBER REVEALED THAT THE DEVICE WAS IMPLANTED FOR LESS THAN (B)(6) BEFORE THE DEATH. THE DEATH OCCURRED GREATER THAN (B)(6) AGO; THEREFORE NO REASONABLE CONTACTS FOR FOLLOW UP EXIST. NO COMPLAINTS, ALLEGATIONS, OR PREVIOUS CONTACTS HAVE BEEN MADE REGARDING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O