BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2792716 · Received October 16, 2012

    Report

    Report Number
    2124215-2012-13991
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 21, 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL THAT LEAD TO INAPPROPRIATE SHOCK. THE PATIENT HAD RECEIVED ANTI-TACHYCARDIA PACING (ATP) WHICH ACCELERATED THE RHYTHM AND A 41 JOULE SHOCK WAS SUCCESSFULLY DELIVERED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SIMILAR INSTANCE TWO DAYS LATER. THE PATIENT'S THRESHOLDS HAD INCREASED A LITTLE; HOWEVER ALL OTHER LEAD MEASUREMENTS WERE STABLE. IT WAS REPORTED THAT THE PATIENT WAS NOT PACER DEPENDENT AND HAD AN UNDERLYING RHYTHM. THE PATIENT LATER UNDERWENT A REVISION PROCEDURE AND IT WAS REPORTED THAT THE RATE/SENSE PORTION OF THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED AS IT HAD "FRAYED". NO FURTHER DETAILS HAVE BEEN REPORTED. A NEW RATE/SENSE LEAD WAS SUCCESSFULLY PLACED.

    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 71 YR Hospitalization| L| R 0184| T165| E110| 4054