BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152107 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00525
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 COULD NOT CONFIRM THE REPORTED EVENT. DEVICE PASSED ALL INCOMING FUNCTIONAL TESTS. ANALYSIS FOUND THE UPPER CASE, LOWER CASE, TWO SIDE BAIL COVERS, AND RING COVER ARE BROKEN. BATTERY RELEASE AND BATTERY DRAWER ARE CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE EXTERNAL PULSE GENERATOR (EPG) FAILED THE ATRIAL AND VENTRICULAR MILLIAMP (MA)OUTPUT TEST FOR THE HIGH RANGE. THE DISTRIBUTED OUTPUT WAS LOWER THAN THE SETTING. THE EPG WAS RETURNED FOR REPAIR AND TEST AND CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252439 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1