BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 4860005 · Received June 22, 2015

    Report

    Report Number
    2938836-2015-27331
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENTS OF HIGH PACING LEAD IMPEDANCE AND SENSING ANOMALY WERE CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. FURTHER EVALUATION NOTED FOREIGN MATERIAL IN THE ATRIAL LEAD BORE WHICH CAUSED THE IMPEDANCE AND SENSING ANOMALIES. THE CAUSE OF THE FOREIGN MATERIAL WAS FOUND TO BE A MANUFACTURING ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, HIGH, OUT OF RANGE PACING LEAD IMPEDANCE AND LOSS OF SENSING WERE OBSERVED. THE LEADS WERE UNABLE TO BE CONNECTED TO THE DEVICE. THE DEVICE WAS NOT IMPLANTED AND WAS REPLACED. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402630 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC 4916775

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR