BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4161035 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01176
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THERE WAS A SELF-TEST ERROR; DEVICE PASS ALL INCOMING FUNCTIONAL TESTS. ANALYSIS ALSO COULD NOT COULD CONFIRM THE REPORTED BATTERY COVER ISSUE. ANALYSIS FOUND THE UPPER CASE, LOWER CASE, HEART BLOCK, AND OUTPUT CONNECTORS ARE BROKEN AND CONTAMINATED. BATTERY RELEASE, KNOBS, LEAD FLEX COVER, MAIN PCB (PRINTED CIRCUIT BOARD) , BATTERY FLEX, AND HEART LEAD FLEX ARE CONTAMINATED. SIDE BAIL COVERS, SIDE BAILS, RING COVER, RING, AND CASE SCREW ARE MISSING. BATTERY CONTACTS ARE COMPRESSED. IT IS NOTED THERE IS EVIDENCE OF NON MEDTRONIC PERSON DISASSEMBLING AND REASSEMBLING; MAIN PCB BOARD CONNECTORS HAVE BLUE SUBSTANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SELF TEST FAILURE ERROR. IT WAS ALSO REPORTED THE BATTERY COVER NEEDS REPAIR. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642526 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1