BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 1667538 · Received April 22, 2010

    Report

    Report Number
    2124215-2010-09091
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ARTICLE AUTHOR WERE UNSUCCESSFUL; HOWEVER, IF MORE INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AND AN UPDATED REPORT WILL BE SENT. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: DOI: 10.1161/CIRCULATIONAHA.106.663807-2007;115;2474-2480; ORIGINALLY PUBLISHED ONLINE APR 30, 2007; CIRCULATION. STEFFEN SCHNEIDER, WERNER SAGGAU, UDO WEISSE AND KARLHEINZ SEIDL. THOMAS KLEEMANN, TORSTEN BECKER, KLAUS DOENGES, MARGIT VATER, JOCHEN SENGES, CARDIOVERTER-DEFIBRILLATORS OVER A PERIOD OF > 10 YEARS. ANNUAL RATE OF TRANSVENOUS DEFIBRILLATION LEAD DEFECTS IN IMPLANTABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A JOURNAL ARTICLE WHICH REVIEWED DATA FROM A STUDY CONDUCTED TO ASSESS THE ANNUAL RATE OF TRANSVENOUS DEFIBRILLATION LEAD DEFECTS RELATED TO FOLLOW-P TIME AFTER LEAD IMPLANTATION. BASED ON THE 990 PATIENTS WHO WERE STUDIED, THE ARTICLE CITED 148 DEFIBRILLATION LEADS FAILED DURING FOLLOW-UP DUE TO: INSULATION DEFECTS (56%), LEAD FRACTURES (12%), LOSS OF VENTRICULAR CAPTURE (11%), ABNORMAL LEAD IMPEDANCE (10%), AND SENSING FAILURE (10%). THE ESTIMATED LEAD SURVIVAL RATES AT 5 AND 8 YEARS AFTER IMPLANTATION WERE 85% AND 60%, RESPECTIVELY. THE ANNUAL FAILURE RATE INCREASED PROGRESSIVELY WITH TIME AFTER IMPLANTATION AND REACHED 20% IN 10-YEAR-OLD LEADS. EIGHT PERFORMANCE ISSUES OCCURRED WITH 27 TOTAL CPI ENDOTAK LEADS (MODELS 0072, 0074, 0075, 0125, 0135, 00145, 0148). ONE OF THE LEAD FAILURES - THE MANUFACTURER AND MODEL/SERIAL NUMBERS ARE UNKNOWN - WAS DETECTED AFTER THE PATIENT WAS RESUSCITATED BY EXTERNAL DEFIBRILLATION AS A RESULT OF VENTRICULAR FIBRILLATION. THIS LEAD HAD SUSTAINED A FRACTURE AND CONSECUTIVE DEFIBRILLATION SHOCKS COULD NOT BE DELIVERED. OVERALL, FOUR PATIENTS WITHIN THE STUDY POPULATION DIED FROM SUDDEN DEATH; THE MANUFACTURER AND MODEL/SERIAL NUMBERS OF THEIR DEVICES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LWS GUIDANT CORPORATION TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death