BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860027 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00806
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE GENERATOR HAD A DAMAGED BATTERY DRAWER, MISSING BAILS AND A BROKEN VENTRICULAR CONNECTOR. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES AS WELL AS THE RING COVER WERE BROKEN, THAT THE BATTERY RELEASE WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED,THE KEYBOARD WAS SCRATCHED, THE SIDE BAIL COVERS WERE MISSING, THE LIQUID CRYSTAL DISPLAY'S GASKET WAS SEEPING INTO THE VIEWABLE AREA AND THAT THE ENCODER FLEX WAS OUT OF SPECIFICATION MECHANICALLY, THAT TRACES ARE SHIFTED IN FLEX. (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 HAD A DAMAGED BATTERY DRAWER, MISSING BAILS AND A BROKEN VENTRICULAR CONNECTOR. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A DAMAGED BATTERY DRAWER, MISSING BAILS AND A BROKEN VENTRICULAR CONNECTOR. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341823 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1