BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1950390 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22298
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. IN ADDITION, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A SEPARATED HEADER. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN CAUSING THE HEADER TO BECOME LOOSE, INDICATED BY THE PRESENCE OF TOOL MARKS ON THE DEVICE CASE, THE ROOT CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. MANUFACTURING ENHANCEMENTS WERE IMPLEMENTED TO MAKE THE BOND MORE ROBUST.

    Additional Manufacturer Narrative · 1

    THE ICD WAS SUCCESSFULLY REPLACED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE ANALYSIS IS COMPLETED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL REPLACEMENT PROCEDURE, THE HEADER FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD BROKEN OFF. IT IS UNKNOWN IF THE HEADER BECAME LOOSENED WHILE IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other