BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 6007680 · Received October 6, 2016

    Report

    Report Number
    2183613-2016-00296
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Report Date
    August 23, 2016
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: AT ANALYSIS IT WAS NOTED THAT THE ATRIUM OUTPUT CONNECTOR WAS BROKEN, ONE BAIL AND ONE BAIL COVER WERE MISSING, THE OVERLAY WAS DAMAGED AND NEEDED TO BE REPLACED AND THAT ON ITS INCOMING TEST IT FAILED ON ITS HEART WIRE CONNECTION. THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION NOTED BUT RETURNED PRODUCT INVESTIGATION FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED FOR A FUNCTIONAL CHECK WITH NO COMPLAINT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654835 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1