BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3090239 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01261
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED. ALL ELECTRICAL PARAMETERS WERE NORMAL. THE NOISE WAS CONFIRMED ON POCKET MANIPULATION. THE POCKET WAS OPENED TO PERFORM A TUG TEST AND THE LEAD WAS FOUND TO BE SECURE IN THE ICD HEADER. POCKET WAS CLOSED AND NOISE WAS STILL PRESENT. THE PHYSICIAN REPLACED THE DEVICE, BUT THE LEAD NOISE WAS STILL PRESENT. THE PHYSICIAN ELECTED TO LEAVE ALONE SINCE THE PATIENT WAS NOT DEPENDENT AND THE NOISE WOULD NOT AFFECT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191378 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention (B)(4)