BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780449 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13096
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 15, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE. THE NOISE WAS OVERSENSED AND LEAD TO INAPPROPRIATE THERAPY FOR THE PATIENT. THE PATIENT WAS SEEN FOR FOLLOW UP. THE DEVICE ARRHYTHMIA LOGBOOK AND ELECTROGRAMS WERE REVIEWED WHICH INDICATED MULTIPLE DAILY EPISODES OF NOISE AND LOSS OF CAPTURE. PACING THRESHOLDS HAD INCREASED AND LOW, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS HAD BEEN RECORDED. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. IN THE OPERATING ROOM THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) WAS ABLE TO RECREATE NOISE WHEN THE PATIENT TURNED ON THEIR SIDES. NOISE WAS NOT ABLE TO BE RECREATED WITH POCKET MANIPULATION. UPON OPENING OF THE POCKET, THE SOURCE OF THE REPORTED CLINICAL OBSERVATIONS WAS IDENTIFIED AS AN INSULATION BREACH. IT APPEARED THAT LEAD HAD BEEN RUBBING ON THE CAN APPROXIMATELY TWO INCHES PROXIMAL OF THE LEAD TIE DOWN. A LEAD REPAIR KIT WAS USED TO COVER THE EXPOSED AREA. THE PACE/SENSE PORTION OF THE LEAD WAS THEN CAPPED. THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS IN SERVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 0185| E102