BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860668 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00761
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; VENTRICULAR OUTPUT CONNECTOR HAD A PIECE OF THE LOWER CASE STUCK DOWN INSIDE THE CONNECTOR. THE LOWER CASE IS BROKEN. ANALYSIS ALSO FOUND THE UPPER CASE IS DAMAGED, BATTERY RELEASE IS CONTAMINATED, ONE SIDE BAIL COVER IS BROKEN, AND ONE SIDE BAIL COVER IS MISSING. THE RING COVER, RING BAIL, ONE SIDE BAIL AND ONE CASE SCREW ARE MISSING. BATTERY CONTACTS ARE COMPRESSED, BATTERY DRAWER IS BROKEN, AND THE KEYBOARD IS SCRATCHED.

    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 THE "+V-" OUTPUT IS BAD. IT WAS ALSO REPORTED THE CASE IS CRACKED. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339394 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1