BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151657 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00572
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE VENTRICULAR OUTPUT CONNECTOR WAS OCCLUDED BY FOREIGN MATERIAL. IT COULD NOT BE CONFIRMED THAT THE DEVICE WOULD NOT CAPTURE, THE DEVICE PASSED ALL FUNCTIONAL TESTING. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN AND CONTAMINATED, THE BATTERY RELEASE WAS CONTAMINATED, ONE BAIL COVER WAS BROKEN, THE RING COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE KEYBOARD WAS SCRATCHED AND THE BATTERY DRAWER O-RING WAS MISSING.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT CAPTURE, AND THE CABLE WAS NOT LOCKING INTO THE OUTPUT CONNECTOR. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253158 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1