BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780006 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12225
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    A NEW PACE/SENSE RV LEAD MAYBE IMPLANTED IN THE NEAR FUTURE, WHILE THE OLD RV LEAD REMAINS IMPLANTED FOR DEFIBRILLATION PURPOSES. THE RV LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC; THEREFORE; THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD REVEALED A RISE IN IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE DECISION WAS MADE TO IMPLANT AN ADDITIONAL RIGHT VENTRICULAR (RV) PACE/SENSE LEAD IN THE NEAR FUTURE DUE TO THE HIGH SENSING IMPEDANCES. THE DETECTION, STIMULATION THRESHOLDS AND SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANG. THE DEFECTIVE DEFIBRILLATION RV LEAD IS NOT PLANNED TO BE EXPLANTED AS IT WILL REMAIN IMPLANTED WITH THE STIMULATION OR SENSING OF THE NEW RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    APPROXIMATLEY ONE WEEK LATER, A REVISION PROCEDURE WAS PERFORMED AND A NEW SENSING LEAD WAS IMPLANTED. ALL MEASURMENTS WERE WITHIN RANGE DURING FINAL TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IMPLANTED AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R