BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152363 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00677
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX. THIS ANALYSIS FURTHER CONFIRMED THE REPORTED EVENT, THE TEST FAILURES WERE DUE TO A DIODE-SUPPRESSOR COMPONENT FAILURE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE HEART LEAD FLEX WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN AND CONTAMINATED, THE LOWER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE CONTAMINATED, THE RING COVER WAS CONTAMINATED, THE HEART BLOCK WAS CONTAMINATED, THE LEAD FLEX COVER WAS CONTAMINATED, THE HEART WIRE CONTACTS WERE CONTAMINATED, THE RING WAS BENT, THE BATTERY DRAWER WAS CONTAMINATED, THE KEYBOARD PAD WAS CONTAMINATED, AND THE SERIAL NUMBER LABEL WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE DOES NOT HAVE VENTRICULAR OUTPUT. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252670 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1