BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 1971780 · Received January 27, 2011

    Report

    Report Number
    2017865-2011-01255
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    January 3, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION INDICATES THERE IS NO SIGNIFICANT DIFFERENCE IN THE OCCURRENCE OF UNDERSENSING BETWEEN THE LOW FREQUENCY ATTENUATION (LFA) FILTER USED IN THESE DEVICES AND THE TACHY FILTER USED IN EARLIER GENERATION DEVICES. REVIEW OF STORED ELECTROGRAMS FROM SPECIFIC EPISODES CONTAINING UNDERSENSING DEMONSTRATES LOW AMPLITUDE SIGNALS THAT ARE NOT SENSED DUE TO AMPLITUDES BEING BELOW THE PROGRAMMED SENSITIVITY THRESHOLD OF THE DEVICE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. PATIENT EXPIRED AT HOME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND IN BED, EXPIRED; CAUSE OF DEATH IS UNKNOWN. INTERROGATION OF THE DEVICE POST DEATH SHOWED THAT THE PATIENT RECEIVED TWO HV SHOCKS AND TWO ROUNDS OF ATP. BOTH HV SHOCKS APPEARED TO CONVERT THE PATIENT TO SINUS. A REVIEW OF THE STORED ELECTROGRAM INDICATED THAT THE DEVICE DETECTED A RETURN TO SINUS, BUT THERE APPEARED TO BE SOME UNDER SENSING OF THE ONGOING VT/ VF. NO THERAPY WAS DELIVERED IN THE LAST RECORDED EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death