BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 3891370 · Received June 24, 2014

    Report

    Report Number
    2649622-2014-07602
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: DTBA1D1, ICD IMPLANTED, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DECEASED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUSPECTED TO BE RELATED TO THE DEATH OF THE PATIENT. THE PHYSICIAN REQUESTED REVIEW OF A CARELINK TRANSMISSION AS DEVICE FUNCTION WAS QUESTIONED. TECHNICAL SERVICES REVIEWED THE TRANSMISSION AND STATED THE DEVICE BEGAN DETECTING NON-SUSTAINED TACHYCARDIA (NST) EPISODES FOR A FULL MINUTE BEFORE IT EVENTUALLY DETECTED A VENTRICULAR FIBRILLATION (VF) EPISODE. THE RHYTHM APPEARED CONSISTENT WITH VF. THE CYCLE LENGTH DURING THE EPISODE SHOWED FLUCTUATION IN AND OUT OF DETECTION ZONES. ISOLATED UNDERSENSING WAS ALSO OBSERVED. THE CYCLE LENGTH VARIATION AND UNDERSENSING BOTH CONTRIBUTED TO DELAYED DETECTION. A SHOCK WAS DELIVERED. AFTER THE SHOCK THE RHYTHM REMAINED A WIDE COMPLEX TACHYCARDIA BUT BECAME MORE REGULAR. BECAUSE IT WAS CONSISTENTLY BELOW A DETECTION ZONE, THE EPISODE TERMINATED. IN SUMMARY, THE DEVICE DETECTED AND DELIVERED THERAPY APPROPRIATELY BASED ON HOW IT WAS PROGRAMMED BUT THE SHOCK WAS INEFFECTIVE. IT WAS ALSO NOTED THAT THE CURRENT EGM IN THE TRANSMISSION SHOWED A DETECTION MARKER INDICATING ANOTHER EPISODE WAS DETECTED. SINCE THERE WERE NO FURTHER TRANSMISSIONS, IT WAS UNKNOWN IF ANY SHOCKS WERE DELIVERED OR ABORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368200 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death 407645 LEAD, 694758 LEAD