BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152567 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00660
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT A SELF-TEST ERROR WAS GENERATED, THE DEVICE PASSED ALL INCOMING TESTS WITH NO ANOMALIES FOUND. (B)(4).

    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 THAT THE EXTERNAL PULSE GENERATOR DISPLAYED AN "0004" ERROR, SELF-TEST FAILURE. IT WAS FURTHER NOTED THAT THIS WAS THE SECOND OCCURRENCE WITH THIS GENERATOR. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR DISPLAYED AN "0004" ERROR, SELF-TEST FAILURE. IT WAS FURTHER NOTED THAT THIS WAS THE SECOND OCCURRENCE WITH THIS GENERATOR. 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
    252082 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1