BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993833 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01067
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 11, 2014
    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

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; UPPER AND LOWER CASES ARE BROKEN. ANALYSIS ALSO FOUND ONE BATTERY LATCH AND ONE BATTERY RELEASE SPRING ARE DAMAGED. THE HIGH RATE COVER, TWO CONTROL KNOBS, ONE CASE SCREW, ONE SIDE BAIL , AND THE RING ARE MISSING. TWO CONTROL KNOBS, TWO BAIL COVERS, AND RING COVER ARE BROKEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A DAMAGED CASE. THE EPG WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND CALIBRATION, ANALYZED, AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469804 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1