BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1862115 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15733
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 5, 2010
    Report Date
    September 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUT POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION NOTED HOLES IN ALL SEAL PLUGS BUT THE DF NEGATIVE SEAL PLUG. A BROKEN WRENCH TIP WAS NOTED IN THE ATRIAL POSITIVE SETSCREW, AND THE SETSCREW WAS STUCK IN THE UP POSITION. THE VENTRICULAR NEGATIVE SETSCREW WAS STUCK IN THE UP POSITION, AND THE SETSCREW HEX SLOT WAS DAMAGED, CONSISTENT WITH IMPROPER OR INCOMPLETE INSERTION OF THE SETSCREW. THE RETAINING RINGS FOR THE DF POSITIVE, VENTRICULAR NEGATIVE, AND BOTH POSITIVE AND NEGATIVE ATRIAL CONNECTORS WERE BENT, CONSISTENT WITH EXCESSIVE FORCE APPLIED TO THE SETSCREW. ANALYSIS CONCLUDED THE REPORTED SETSCREW DIFFICULTY WAS LIKELY INDUCED DURING THE PROCEDURE. 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. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS (NOVEMBER 27, 2007) ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING AN EXPLANT PROCEDURE, A SETSCREW WAS STUCK. SEVERAL DIFFERENT TORQUE WRENCHES WERE USED BEFORE THE SETSCREW COULD BE SUCCESSFULLY LOOSENED. UPON RETURN, INITIAL ROUTINE DEVICE ANALYSIS NOTED THE DEVICE FAILED TO MEET LONGEVITY SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1