BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1041094 · Received May 12, 2008

    Report

    Report Number
    6000144-2008-00133
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 28, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    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. EVALUATION SUMMARY: DISTAL CONDUCTOR FRACTURED; FULL LEAD RETURNED FOR ANALYSIS. ANALYSIS OF THE IPG IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2DR21 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4965 IMPLANTABLE PACING LEAD