BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2780230 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12303
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 9, 2012
    Report Date
    September 9, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD IS NOT EXPECTED TO BE RETURNED AS IT WAS SURGICALLY ABANDONED. 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 IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD WAS ADMITTED DUE TO DIZZINESS. IT WAS REPORTED, THE PATIENT HAD FALLEN THE DAY BEFORE BEING ADMITTED. THE HOSPITAL MONITOR REVEALED PAUSES IN PACING GREATER THAN THREE SECONDS. INTERROGATION OF THE DEVICE REVEALED PACING THRESHOLD MEASUREMENTS HAD INCREASED. PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS WERE ALSO OBSERVED. REVIEW OF THE LOGBOOK REVEALED NUMEROUS VENTRICULAR FIBRILLATION (VF) EPISODES WITH OVERSENSED NOISE. AN INVASIVE PROCEDURE WAS PERFORMED THE NEXT DAY. THIS LEAD WAS SURGICALLY ABANDONED AND WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4513| 0154| N118| H135| (B)(4)| H175| 1851