BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780574 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12910
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS EVALUATED FOR HEART RATES IN THE 30'S-40'S. THE PATIENT WAS IN COMPLETE HEART BLOCK. THE PATIENT'S GENERATOR WAS PROGRAMMED TO PACE AND SENSE IN BOTH THE ATRIUM AND THE VENTRICLE. THERE WERE RV PAUSES GREATER THAN 2 SECONDS DUE TO NOISE AND OVERSENSING. IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE. ADDITIONALLY, THERE WERE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND AN INCREASE IN PACING IMPEDANCES FROM 534 OHMS TO 1,800 OHMS. THE PATIENT WAS BROUGHT INTO THE CATH LAB AND AN EXTERNAL PACER WAS PLACED. THE PHYSICIAN ABANDONED THE PATIENT'S CHRONIC SYSTEM DUE TO SUBCLAVIAN OCCLUSION AND IMPLANTED A NEW SYSTEM ON THE OTHER SIDE. IT WAS BELIEVED THAT THIS LEAD WAS FRACTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R E110| 0184| 1290| 4087| 4086