BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3212680 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10075
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SERVICES CONSULTANT RECOMMENDED A LEAD REVISION. IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL PENDING A LEAD REPLACEMENT PROCEDURE. BEFORE THE PROCEDURE, THE PHYSICIAN PERFORMED A SUBCLAVIAN VENOGRAM THAT REVEALED AN OCCLUSION. THE PATIENT WAS RESCHEDULED FOR A LEAD EXTRACTION AND IMPLANT OF A NEW SYSTEM ON THE RIGHT SIDE IN TWO WEEKS. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION REGARDING THE SCHEDULED PROCEDURE IS PROVIDED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS LEAD REMAINS IN SERVICE. THE PATIENT AND LEAD CONTINUE TO BE MONITORED WITH THE PATIENT'S HOME REMOTE MONITORING SYSTEM. A LEAD REVISION WAS STILL INTENDED, BUT HAS NOT BEEN SCHEDULED OR PERFORMED. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS OVERSENSED, CAUSING SOME PACING TO BE INHIBITED. A TECHNICAL SERVICES CONSULTANT REVIEWED STORED ELECTROGRAMS AND DISCUSSED THE NOISE WAS MECHANICAL IN APPEARANCE, CONSISTENT WITH A LEAD FRACTURE. THE PATIENT WAS NOT SYMPTOMATIC DURING THE EPISODES. THE NOISE COULD NOT BE REPRODUCED, AND AN X-RAY DID NOT REVEAL ANY LEAD ANOMALIES. RV SENSITIVITY WAS DECREASED IN THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313077 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 1793| T177| 0145| E102