BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951414 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00008
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT. THE HEART LEAD FLEX WAS OUT OF ELECTRICAL SPECIFICATION. FLUID INGRESS WAS ALSO FOUND ON THE HEART LEAD FLEX AND IN THE LOWER CASE WHERE THE HEART LEAD FLEX WAS. THE LIQUID CRYSTAL DISPLAY (LCD) WAS MISSING SEGMENTS, AND THE SIDE BAIL COVERS WERE BROKEN. THE UPPER AND LOWER CASES, HEART BLOCK, LEAD FLEX COVER, HEART WIRE CONTACTS, AND BATTERY FLEX WERE CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR (EPG) THE OUTPUT AND EMERGENCY MODE WERE FOUND TO BE OUT OF SPECIFICATION. THE EPG WAS RETURNED FOR SERVICE AND REPAIR. NO PATIENT INVOLVEMENT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR (EPG), THE OUTPUT AND EMERGENCY MODE WERE FOUND TO BE OUT OF SPECIFICATION. THE EPG WAS RETURNED FOR SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55647 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTE MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1