BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1775010 · Received July 29, 2010

    Report

    Report Number
    2124215-2010-13322
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 21, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND A NEW BOSTON SCIENTIFIC ICD WAS SUCCESSFULLY IMPLANTED. THE REPRESENTATIVE NOTED THERE APPEARED TO BE SOME MARKINGS ON THE BACK OF THE CAN WHERE THE HIGH VOLTAGE LEAD MAY HAVE BEEN IN CONTACT WITH THE TITANIUM CASING. THE DEVICE WILL BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. MICROSCOPIC VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED AN ELECTROCAUTERY MARK ON THE CASING SURFACE. ALL SEAL PLUGS WERE INTACT AND ALL SETSCREWS MOVED FREELY. A LEAD WAS INSERTED INTO EACH LEAD BARREL AND EACH SET SCREW WAS TIGHTENED ON THE LEAD PIN WITHOUT DIFFICULTY. LEAD EXTRACTION TESTING REVEALED THAT THE LEAD REMAINED IN PLACE WHEN MODERATE TO STRONG EXTRACTION FORCE WAS APPLIED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING DEFIBRILLATION THRESHOLD TESTING (DFT'S) AT THE DEVICE REPLACEMENT PROCEDURE THE PATIENT DID NOT CONVERT AT 21 JOULES (J) OR 31 J. A LOUD 'POP' WAS HEARD WHEN THE 31 J SHOCK WAS DELIVERED. THE PATIENT WAS EXTERNALLY DEFIBRILLATED. UPON INTERROGATION, A LOW SHOCK IMPEDANCE FAULT SCREEN WAS DISPLAYED. SHOCK IMPEDANCE WAS LESS THAN 20 OHMS. SHOCK IMPEDANCE WAS 39 OHMS PRIOR TO DFT'S. TECHNICAL SERVICES (TS) DISCUSSED THAT THE SYSTEM MAY BE COMPROMISED AND THE LEAD AND DEVICE SHOULD NOW BE REPLACED. THE PHYSICIAN THOUGHT THAT INITIALLY THE PROXIMAL PIN OF THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS NOT ALL OF THE WAY INTO THE DEVICE HEADER. THE PIN WAS REMOVED FROM THE HEADER AND REINSERTED ALL OF THE WAY INTO THE CONNECTOR BLOCK. IMPEDANCE WAS TESTED AGAIN AND WAS 39-40 OHMS. TS STRONGLY EMPHASIZED REPLACING LEAD AND DEVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 0125| 1640| 0185| 4269| 1860| 4470| T135| E102