BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140478 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17503
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL FOLLOWING SYNCOPAL EVENTS. UPON REVIEW, THE ICD SYSTEM EXHIBITED OVERSENSING RESULTING IN PACING INHIBITION AND ASYSTOLE WITH PAUSES OF UP TO 7 SECONDS. IT WAS NOTED THAT THE PATIENT HAS FREQUENT EPISODES OF PAROXYSMAL ATRIAL FIBRILLATION (AF) AND THAT SEVERAL VENTRICULAR TACHYCARDIA (VT) EVENTS WERE STORED TO THE DEVICE. UPON CLOSER REVIEW, DAILY MEASUREMENTS SHOWED STABLE IMPEDANCE MEASUREMENTS BUT FLUCTUATING SENSING VALUES FROM LESS THAN 1 MV UP TO 25 MV. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED SEVERAL POSSIBLE CAUSES AND REMEDIES. A REVISION PROCEDURE WAS PERFORMED WHEREIN THE PACE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618820 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 1645| 1625| 4470| F110| 0185| 0072