BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3043238 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01888
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. 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, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS SUCCESSFULLY REMOVED, REPLACED AND RETURNED FOR ANALYSIS. THERE WAS CONCERN THAT THE DEVICE BATTERY HAD EXPERIENCED A RAPID BATTERY DEPLETION DUE TO AN INCREASED CHARGE TIM FROM EIGHT TO TWENTY SECONDS. VISUAL OBSERVATION REVEALED THE LEADS WERE REVERSED IN THE DEVICE HEADER. THE CONNECTIONS WERE PROPERLY RESEATED INTO THE HEADER AND REMAIN IMPLANTED. NO ADVERSE PATIENT SYMPTOMS WERE EXPERIENCED DUE TO THE REPORTED OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED OVERSENSING. IT WAS THOUGHT THIS WAS DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI). AS THIS DEVICE IS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI), A REPLACEMENT PROCEDURE IS INTENDED IN THE NEAR FUTURE. ALL MEASUREMENTS WERE NORMAL AND NO INAPPROPRIATE SHOCKS HAD BEEN DELIVERED AS A RESULT OF THE OVERSENSING. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. AFTER REVIEWING THE ELECTROGRAMS, IT WAS THOUGH THE HIGH VOLTAGE LEADS ARE REVERSED IN THE DEVICE HEADER. WHEN THE HIGH VOLTAGE LEADS ARE REVERSED, THE DEVICE IS SENSING BETWEEN DISTAL COIL/CAN AND PROXIMAL COIL AND MYOPOTENTIALS FROM THE PECTORAL MUSCLES MAY BE PICKED UP ON THE SHOCK CHANNELS AND AMPLIFIED. EMI COULD NOT BE RULED OUT. VERIFICATION OF THE CONNECTION WAS RECOMMENDED DURING THE REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146728 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1