BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212601 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08970
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    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

    THE NEXT DAY, A LEAD REVISION WAS PERFORMED. WHEN THE POCKET WAS OPENED, INSULATION DAMAGE WAS NOTED NEAR THE CLAVICLE. THE PHYSICIAN BELIEVED THE INSULATION WAS DAMAGED DUE TO CLAVICULAR PRESSURE FROM A VERY MEDIAL VENIPUNCTURE. THE LEAD'S HELIX WAS RETRACTED TO REMOVE THE LEAD, BUT GENTLE TRACTION PRODUCED FIRM RESISTANCE AND THE PHYSICIAN ELECTED TO SURGICALLY ABANDON THE LEAD. THE INSULATION BREACH WAS REPAIRED. A NEW RV LEAD WAS IMPLANTED AND CONNECTED TO THE CHRONIC DEVICE, WITH GOOD LEAD MEASUREMENTS OBTAINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SEEN IN THE CLINIC FOR A ROUTINE DEVICE FOLLOW-UP. THE PATIENT REPORTED RECEIVING A SHOCK FROM THE DEVICE. UPON INTERROGATION, THE DEVICE HAD STORED MULTIPLE NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES AND MANY ANTI-TACHYCARDIA PACING (ATP) EPISODES THAT WERE ALL CAUSED BY OVERSENSING OF NOISE ON THE RV CHANNEL. LEAD MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE, WITH THE EXCEPTION OF TWO PACING IMPEDANCE MEASUREMENTS THAT WERE LESS THAN 200 OHMS. THE NOISE WAS ABLE TO BE REPRODUCED. THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS SENT HOME UNTIL THE LEAD REVISION COULD OCCUR THE FOLLOWING DAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314105 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R 0184| E102