BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4372243 · Received December 30, 2014

    Report

    Report Number
    2938836-2014-19359
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    October 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATED THAT ADDITIONAL NON-SUSTAINED VENTRICULAR FIBRILLATION/VENTRICULAR TACHYCARDIA EPISODES WERE OBSERVED DUE TO LEAD NOISE. THE LEAD WAS SUSPECTED TO BE DAMAGED. THE NOISE WAS NOT REPRODUCIBLE WITH THE LEAD PROVOCATIVE TEST AND THE POCKET MANIPULATION TEST. THE PHYSICIAN ELECTED NOT TO TAKE FURTHER ACTION. THE PATIENT WAS IN GOOD MEDICAL CONDITION AND WILL BE FOLLOWED-UP NORMALLY.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT MULTIPLE EPISODES OF NON-SUSTAINED OVERSENSING AND NON-SUSTAINED VT DUE TO NOISE WERE OBSERVED. POCKET MANIPULATION AND PROVOCATIVE TESTING DID NOT REPRODUCE THE NOISE. POOR LEAD TO HEADER CONNECTION OR LEAD DAMAGE WAS SUSPECTED. PHYSICIAN ELECTED TO NOT TAKE ANY ACTION AT THIS TIME AND THE PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE EPISODES OF NON-SUSTAINED OVERSENSING WERE OBSERVED. REVIEW OF EPISODES REVEALED CROSSTALK. ALTHOUGH A CONNECTION ISSUE WAS SUSPECTED, X-RAY REVEALED NO ANOMALIES WITH THE HEADER-LEAD CONNECTION. PROGRAMMING CHANGES WERE MADE BUT CROSSTALK WAS STILL PRESENT. PATIENT WILL BE MONITORED. PATIENT MEDICAL CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857675 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3361-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1