BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152106 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00527
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THAT THE VENTRICULAR CABLE CONNECTION AND UPPER/LOWER CASES WERE BROKEN. THE BATTERY DRAWER AND ONE BAIL COVER WERE ALSO BROKEN, THE BATTERY CONTACTS COMPRESSED, RING COVER, HEART BLOCK, LEAD FLEX COVER, HEART WIRE CONTACTS, AND UPPER/LOWER CASES CONTAMINATED, THE RING BENT, THE KEYBOARD SCRATCHED, AND THE SERIAL NUMBER LABEL DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A BROKEN CASE AND A BROKEN VENTRICULAR CABLE CONNECTION. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252751 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1