BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213155 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09827
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 8, 2013
    Report Date
    August 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL IFNORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A FOLLOW UP VISIT WAS PERFORMED. INTERROGATION REVEALED NO EPISODES OF NOISE OR NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE RIGHT VENTRICULAR LEAD IMPEDANCE HAS REMAINED STABLE. THE PATIENT WITH THIS LEAD HAS SOME UNDERLYING INTRINSIC RHYTHM. A DECISION WAS MADE TO FURTHER MONITOR THIS DEVICE AND LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN EDUCATIONAL REVIEW WITH CARDIAC TECHNICIANS, IT WAS REPORTING DIFFICULTY REVIEWING EPISODES THAT HAD BEEN OVERWRITTEN. REPORTEDLY, ANTI-TACHYCARDIA PACING (ATP) THERAPY HAD BEEN DELIVERED FOR AN EPISODE OF TACHYCARDIA AND THE EPISODE COULD NOT BE VIEWED. A FURTHER REVIEW WAS PERFORMED REVEALING NOISE THAT CAUSED OVERSENSING RESULTING IN PACING INHIBITION OF TWO TO THREE BEATS HAD OCCURRED. THIS INHIBITION OF THERAPY RESULTED IN VENTRICULAR PAUSES AND COMPLETE HEART BLOCK. A FOLLOW UP VISIT WILL BE PERFORMED IN THE FUTURE. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313151 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L 4136| T165| 0185