BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2811426 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01877
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BE) REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) AUTOMATICALLY SHUT OFF WHILE PACING. THE BE USED A FLUKE 867B TO TEST, BUT WAS UNABLE TO REPRODUCE ISSUE. THE BE ASSUMES THE EPG WAS IN USE ON PATIENT, BUT DOES NOT HAVE ANY OTHER INFORMATION. THE EPG WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention