BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152548 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00661
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE GENERATOR DID NOT PACE AT THE SET RATE. ANALYSIS DID FIND THAT THE HIGH RATE COVER WAS MISSING, THAT THE UPPER AND LOWER CASES, TWO SIDE BAIL COVERS AND THE RING COVER WERE BROKEN, ONE KNOB SPRING WAS DAMAGED AND THE RING WAS BENT. (B)(4).

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 6 WEEKS AGO, A FIELD CORRECTIVE ACTION WAS INITIATED FOR THE SUSPECT MEDICAL DEVICE NOTED WHICH MAY INVOLVE INTERMITTENT PERFORMANCE OF CERTAIN PACING FUNCTIONS.

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE RATE WAS HIGH WHEN SET LOW. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RATE WAS HIGH WHEN SET LOW. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253166 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1