BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4130774 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16107
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO ER AFTER RECEIVING A VIBRATORY PATIENT NOTIFIER. EPISODES OF NON SUSTAINED VENTRICULAR OVERSENSING WAS OBSERVED. REVIEW OF EGMS REVEALED POSSIBLE MYOPOTENTIAL OVERSENSING. OVERSENSING WAS ABLE TO BE RECREATED WHEN PATIENT TOOK DEEP BREATHS. PROGRAMMING CHANGES WERE MADE TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608418 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR