BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2812535 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01866
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 1

    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 COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED ALL INCOMING FUNCTIONAL TESTING. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, ALL THREE CONTROL KNOBS WERE CRACKED, THE HEART LEAD FLEX CONNECTOR WAS BROKEN, AND THE LIGHT-EMITTING DIODE (LED) FLEX CONNECTOR WAS NOT FULLY SEATED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE TOP SEGMENTS OF THE RAPID ATRIAL PACING WERE FLICKERING OUT. AFTER HANDLING THE DEVICE FOR AWHILE, IT CAME BACK ON STEADY. THE DEVICE WAS RETURNED FOR REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING ROUTINE CHECKOUT OF THE DEVICE AND NOTICED THE RAP (RAPID ATRIAL PACING) TOP SEGMENTS ARE MISSING IN THE DISPLAY. THE DEVICE IS BEING RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THE TOP SEGMENTS OF THE RAPID ATRIAL PACING WERE FLICKERING OUT. AFTER HANDLING THE DEVICE FOR AWHILE, IT CAME BACK ON STEADY. THE DEVICE WAS RETURNED FOR REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOMED WAS DOING ROUTINE CHECKOUT OF THE DEVICE AND NOTICED THE RAP (RAPID ATRIAL PACING) TOP SEGMENTS ARE MISSING IN THE DISPLAY. THE DEVICE IS BEING RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other