BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3904518 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11806
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    August 1, 2012
    Report Date
    April 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ANOTHER MANUFACTURE'S RIGHT VENTRICULAR (RV) LEAD AND THIS DEFIBRILLATOR EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) WITH NO NOISE. THERE WAS STILL APPROPRIATE PACING AT REGULAR INTERVALS. AT THAT TIME THE DEVICE WAS REPROGRAMMED WITH EXTENDED BIPOLAR LEFT VENTRICULAR (LV) PACING TO UNIPOLAR LV PACING. EIGHT MONTHS LATER THE PATIENT PRESENTED TO THE CLINIC WITH COMPLAINTS OF LIGHTHEADEDNESS. REVIEW OF THE REMOTE HOME MONITORING SYSTEM DATE FOUND OVERSENSING OF NOISE LEADING TO PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE. THE RV IMPEDANCE WAS NOTE TO TYPICALLY BE AROUND 600 OHMS WITH AN OCCASIONAL SPIKE. THE OCCASIONAL INCREASED IMPEDANCE READING DOES NOT GO ABOVE 1000 OHMS AND APPEARS TO BE OCCURRING MORE NOW THEN IN THE PAST. EVERYTHING ELSE APPEARS STABLE AND THE NOISE WAS NOT ABLE TO BE REPRODUCED IN THE CLINIC. SUBSEQUENTLY THE RV SENSITIVITY WAS DECREASED TO 1.0 MILLIVOLT IN AN ATTEMPT TO AVOID PACING INHIBITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY ONE YEAR EARLIER THERE WAS OVERSENSING OF NOISE WHICH LEAD TO INAPPROPRIATE SHOCKS. AT THAT TIME, THE PACE SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND ANOTHER MANUFACTURER'S LEAD WAS IMPLANTED. THE SHOCK PORTION OF THE LEAD AND THE DEVICE REMAINED IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384946 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR H179| 0184| 5068| MISMATCH| N118| 4513| 1184