BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2810945 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01850
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 21, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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: (B)(4): ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL TESTING. ANALYSIS DID FIND THAT THE UPPER AND LOWER CASES WERE BROKEN AND THE RING WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING PREVENTIVE MAINTENANCE ON THE EPG (EXTERNAL PULSE GENERATOR), THE SENSING WAS FOUND TO BE OUT OF SPECIFICATION. THE EPG WAS RETURNED FOR REPAIR WITH A REPORT THE SENSITIVITY WAS NOT ACCURATE AT THE HIGH END OF THE RANGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other