BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1771279 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12225
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    May 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE REMAINS IMPLANTED. UPON REMOVAL, THE DEVICE WILL BE RETURNED TO BOSTON SCIENTIFIC CRM FOR ANALYSIS. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS REMOVED AND REPLACED ON (B)(6), 2010. THE EXPLANTED DEVICE REMAINED WITH THE PATIENT AND WAS NOT RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT WAS IMPLANTED ON (B) (6) 2005 DECLARED ELECTIVE REPLACEMENT INDICATOR ON (B) (6) 2010. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE BATTERY VOLTAGE WAS AT 2.57V WITH A CHARGE TIME OF 24.8 SECONDS. ALL OTHER MEASUREMENT VALUES WERE WITHIN NORMAL PARAMETERS. A REPLACEMENT PROCEDURE WAS SCHEDULED FOR THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Other| R