BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041750 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-04086
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ELECTROGRAMS RECEIVED VIA LATITUDE SHOWED OVERSENSING ON THE ATRIAL, SHOCK, AND VENTRICULAR CHANNELS. THE PATIENT EXPERIENCED TWO EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA DUE TO DIAPHRAGMATIC OVERSENSING THAT LED TO PACING INHIBITION RESULTING IN ASYSTOLE LASTING LONGER THAN TWO SECONDS. THE PATIENT IS PACER-DEPENDENT WITH CHRONIC ATRIAL FIBRILLATION AND INTRINSIC RATE OF APPROXIMATELY 30 BPM. INTERROGATION OF THE DEVICE REVEALED NOISE ONLY ON THE RV RATE/SENSE CHANNEL. IT WAS ALSO NOTED AT THAT TIME THAT THE RA LEAD, A COMPETITOR'S PRODUCT, WAS PLUGGED INTO THE PACE/SENSE PORTION OF THE RV PORT, AND THE PACE/SENSE PORTION OF THE RV LEAD WAS PLUGGED INTO THE RA PORT. THE DEVICE IS PROGRAMMED TO VVIR, WITH THE INTENT TO ELECTRICALLY ABANDON RIGHT ATRIAL THERAPY. NOISE COULD NOT BE RECREATED DURING DEVICE TESTING AND NO PATIENT SYMPTOMS WERE ASSOCIATED WITH THE PACING INHIBITION. ALL LEAD MEASUREMENTS REMAINED STABLE AND WITHIN NORMAL LIMITS. THE PATIENT'S PHYSICIAN PLANS TO CONTINUE MONITORING THIS SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening 4542| H210| 5068| 0185| (B)(4)