BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153259 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00603
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, THE HEART BLOCK WAS CONTAMINATED, THE HEART WIRE CONTACTS WERE CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER WAS BROKEN, AND THE HEART LEAD FLEX WAS REPLACED AS A PREVENTATIVE DUE TO TRACES NOT ALIGNING IN THE CONNECTOR. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. THIS ANALYSIS FOUND THAT A CAPACITOR COMPONENT FAILURE CAUSED THE DEVICE BATTERY REMOVAL TEST FAILURE.

    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) SHUT OFF AS SOON AS THE NURSE WENT TO CHANGE THE BATTERY. THE NURSE HAD TURNED ON THE EPG PRIOR TO IT BEING ATTACHED TO THE PATIENT, AND THIS IS WHEN IT WAS DISCOVERED NEW BATTERIES WERE NEEDED. ANOTHER EPG WAS USED, WITH NO COMPLICATIONS. THE BIOMEDICAL ENGINEER TESTED THE EPG WITH A KNOWN GOOD BATTERY, AND IT SHUT OFF AFTER THREE SECONDS WHEN THE BATTERY DRAWER WAS OPENED, INSTEAD OF STAYING ON FOR FIFTEEN SECONDS. THE EPG WAS RETURNED FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255116 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention