BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153485 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00609
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX. THIS ANALYSIS FOUND THAT A DIODE-SUPPRESSOR COMPONENT FAILURE CAUSED THE OUT OF SPECIFICATION VENTRICULAR OUTPUT.

    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 FOUND THE HEART LEAD FLEX WAS OUT OF ELECTRICAL SPECIFICATION. ANALYSIS ALSO FOUND THE LOWER CASE, THE RING COVER, AND THE LEAD FLEX COVER ARE CONTAMINATED. BOTH BAIL COVERS ARE BROKEN AND ONE BATTERY CONTACT IS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THIS UNIT HAD BEEN MISSING FOR A NUMBER OF YEARS AND WHEN THE EPG (EXTERNAL PULSE GENERATOR) WAS DISCOVERED THERE WAS NO OUTPUT ON THE VENTRICULAR CHANNEL. THE EPG WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256940 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1