BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152999 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00592
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 CONFIRMED THE REPORTED EVENT, THE LOWER CASE AND ATRIAL OUTPUT CONNECTOR WERE BROKEN. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, THE BATTERY RELEASE, HEART BLOCK AND HEART WIRE CONTACTS WERE CONTAMINATED, THE LEAD FLEX COVER WAS CORRODED, ONE CASE SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS SCRATCHED, AND THE BATTERY DRAWER O-RING WAS MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EPG (EXTERNAL PULSE GENERATOR) WAS SENT TO THE BIOMEDICAL ENGINEER, FROM THE INTENSIVE CARE UNIT (ICU), WITH THE BACK CASING CRACKED AND A BROKEN AND LOOSE ATRIAL OUTPUT CONNECTOR. IT WAS NOTED THAT THE EPG MAY HAVE BEEN DROPPED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254354 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1