BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1041822 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34813
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE DEVICE WOULD NOT PAUSE PACING UNLESS IT WAS OVERSENSING. TS RECOMMENDED CHECKING FOR EVIDENCE OF NOISE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN INVASIVE PROCEDURE WAS PERFORMED AND THE RATE/SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO OVERSENSED NOISE RESULTING IN PACING INHIBITION. A DECREASE IN PACING IMPEDANCE MEASUREMENTS WAS NOTED AT THE TIME OF THE PROCEDURE. A NEW/RATE SENSE LEAD WAS SUCCESSFULLY IMPLANTED AND THE SHOCK PORTION OF THIS LEAD REMAINS IN SERVICE. 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 CRM RECEIVED INFORMATION THAT THIS RECENTLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THIS CHRONIC IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED PAUSES IN PACING FOLLOWING IMPLANT. IT WAS ALSO NOTED THAT PAUSES IN PACING WERE NOTICED WITH THE PREVIOUS DEVICE AT THE CHANGE-OUT PROCEDURE. THE LOCAL AREA SALES REPRESENTATIVE INQUIRED IF THE DEVICE WOULD PURPOSELY PAUSE PACING. TO DATE, THERE HAVE BEEN NO REPORTED PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R THE DEVICE H177/501171 WAS IMPLANTED 04-APR-2004| THE DEVICE 4469/418277 WAS IMPLANTED 04-APR-2004| THE DEVICE 4047/086150 WAS IMPLANTED 02-APR-2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2004| THE DEVICE (B)(4) WAS IMPLANTED (B)(4) 2008| THE DEVICE H227/559405 WAS IMPLANTED 26-MAR-2008