BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-16366

    MDR report key: 1801338 · Received August 16, 2010

    Report

    Report Number
    2124215-2010-16366
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    ODL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT WAS MADE TO GAIN ADDITIONAL INFORMATION FROM THE ARTICLE AUTHOR(S) AND THIS HAS BEEN UNSUCCESSFUL. THE FINDINGS OF THE STUDY ARE SUMMARIZED IN THE ARTICLE: JOSEPH W. HACKLER, ZHIYUAN SUN, BRUCE D. LINDSAY, BRUCE L. WILKOFF, MARK J. NIEBAUER, PATRICK J. TCHOU, MINA K. CHUNG. EFFECTIVENESS OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR LEAD COIL TREATMENTS IN FACILITATING EASE OF EXTRACTION. HEART RHYTHM. 2010, JULY; 7 (7): 890-897. (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A STUDY DESIGNED TO EVALUATE THE EFFECTIVENESS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD COIL TREATMENTS REGARDING THEIR EASE OF EXTRACTION. THE STUDY INVOLVED 329 PATIENTS. THERE WERE 284 PATIENTS WHO HAD STANDARD COIL ICD LEADS AND 45 PATIENTS HAD TREATED COIL ICD LEADS; 17 WITH POLYESTER (EPTFE) AND 28 WITH MEDICAL ADHESIVE BACK-FILLED (MABF). THE MAJORITY OF EXPLANTS WERE RELATED TO INFECTION (N=301). OTHER REASONS FOR EXPLANT WERE INCESSANT PAIN (N=1), LEAD FRACTURE (N=2), DEVICE RECALL (N=1), LEAD NO LONGER NEEDED/PATIENT REQUEST (N=11), PROARRHYTHMIA (N=1), AND THE UNKNOWNS (N=11). TWO PATIENTS HAD ENCOUNTERED PERICARDIAL EFFUSIONS. ONE OF THESE PATIENTS REQUIRED OPERATIVE REPAIR. OF THE TOTAL POPULATION, THE MEAN AGE WAS (B)(6) YEARS WITH 80% BEING MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ODL GUIDANT PUERTO RICO BV TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention