BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860111 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00800
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; UPPER CASE, LOWER CASE AND VENTRICULAR OUTPUT CONNECTOR ARE BROKEN. ANALYSIS ALSO FOUND THE BATTERY RELEASE AND SIDE BAIL COVERS ARE CONTAMINATED. LEAD FLEX COVER IS CORRODED, BATTERY CONTACTS ARE COMPRESSED, BATTERY DRAWER IS DAMAGED, SERIAL NUMBER LABEL IS TORN, AND ENCODER FLEX IS OUT OF MECHANICAL SPECIFICATION (TRACES ARE NOT CENTERED).

    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 THE VENTRICULAR CONNECTOR AND CASE ARE BROKEN. THE DEVICE WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339966 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1