BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1864045 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15637
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    October 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION. THE CLINICAL OBSERVATION OF OVERSENSING WAS UNABLE TO BE REPRODUCED DURING LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. UPON COMPLETION OF ANALYSIS THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD BEEN LOST TO FOLLOW-UP. IT WAS REPORTED THAT THE PATIENT'S MONITORING VOLTAGE WAS 2.50 VOLTS AND THERE WERE CONCERNS THAT THIS PRODUCT WAS DEPLETION PREMATURELY. ADDITIONALLY, THE DEVICE MEMORY REVEALED THAT THE THERE WAS ONE DIVERTED EPISODE THAT LOOKED LIKE ELECTROMAGNETIC INTERFERENCE, THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. IT WAS REPORTED THAT THE PHYSICIAN PLANS TO SEE THIS PATIENT ON A MONTHLY BASIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PRODUCT WAS EXPLANTED AND REPLACED FOR NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 4086| T165| 0184