BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3211286 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08788
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE DEFIBRILLATION LEAD WAS ADMITTED TO THE HOSPITAL DUE TO A NON-DEVICE RELATED REASON. INTERMITTENT LOSS OF CAPTURE WAS OBSERVED ON TELEMETRY. INTERROGATION OF THE DEVICE REVEALED A DECREASE IN R-WAVE MEASUREMENTS AND AN INCREASE IN PACING THRESHOLD MEASUREMENTS. ADDITIONALLY, PACING IMPEDANCE MEASUREMENTS HAD INCREASED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311498 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0145| 1851| 4054| 0185| A155| 4470| E143