BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151526 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00509
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT DURING REPAIR OF THE DEVICE, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE RING COVER AND RING BAIL WERE MISSING, AND ONE SIDE BAIL COVER WAS BROKEN. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS CONDUCTED A FULL FUNCTIONAL TEST, ALL TESTS PASSED. CONCLUSION: COULD NOT CONFIRM REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR'S SENSITIVITY WAS OUT OF SPECIFICATION. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253377 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1