BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152868 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00582
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL AND BENCH TESTING. IT WAS NOTED THAT THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, THE SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING BAIL WAS BENT, AND THE KEYBOARD WAS SCRATCHED.

    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 EPG (EXTERNAL PULSE GENERATOR) HAD TROUBLE WITH ATRIAL PACING, WHEN TESTING, IT DID NOT GET RELIABLE ATRIAL SENSITIVITY READINGS AT FIRST. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257846 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1