BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1951491 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22948
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-08 TO Z-0053-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, IT WAS DETERMINED THAT THE DECISION RATIONALE ASSOCIATED WITH THIS REPORTED INFORMATION SHOULD BE UPDATED FROM MALFUNCTION TO SERIOUS INJURY, GIVEN THE EARLY SURGICAL INTERVENTION AS A RESULT OF A PRODUCT PERFORMANCE ISSUE. THIS DEVICE STILL HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC. THE DEVICE HAS BEEN REQUESTED FOR RETURN. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE HAS BEEN EXPLANTED BUT NOT YET RETURNED TO THE BOSTON SCIENTIFIC POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS PURPOSES. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY AND INITIALLY COMMUNICATED ON (B)(6) 2007, DISPLAYED A BATTERY STATUS OF END OF LIFE (EOL). THE MONITORING VOLTAGE WAS 2.45 VOLTS AND THE CHARGE TIME WAS 31 SECONDS. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THIS DEVICE WAS RECOMMENDED FOR IMMEDIATE EXPLANT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    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 72 YR 0145| 1790| T135