BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3052810 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04308
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN ANOMALY IN AN OXIDE LAYER WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSED A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN THE RAPID DEPLETION OF THE BATTERY THAT WAS OBSERVED CLINICALLY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, THE CHRONIC LEADS WERE TESTED AND CONFIRMED TO BE FUNCTIONING PROPERLY. THE LEADS REMAIN IN SERVICE WITH THE NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IMPLANTED BUT IS NOT ABLE TO PROVIDE THERAPY. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL WITH WORSENING HEART FAILURE SYMPTOMS. THE DEVICE WAS NOT ABLE TO BE INTERROGATED WITH TWO DIFFERENT PROGRAMMERS. NO PACING SPIKES WERE OBSERVED ON THE ECG. IT WAS REPORTED THAT THE PATIENT HAD NOT HAD A DEVICE CHECK FOR APPROXIMATELY ONE YEAR. THE PATIENT HAD AN UNDERLYING RHYTHM. THE PHYSICIAN BELIEVED THE DEVICE DEPLETED PREMATURELY, AND THIS MALFUNCTION OF THE DEVICE CAUSED THE PATIENT'S WORSENING HEART FAILURE SYMPTOMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A REPLACEMENT PROCEDURE WAS PLANNED FOR WITHIN THE NEXT THREE WEEKS OR IN THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156551 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R