BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY AVT

    MDR report key: 2161623 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07293
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    October 1, 2010
    Report Date
    April 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ACCORDING TO A PATIENT ADVOCATE, THIS DEVICE, WHICH WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON 3/10/2007, EXHIBITED A GOOD BATTERY STATUS AT A ROUTINE DEVICE CHECK IN JULY 2010. THEN, IN OCTOBER, 2010, THE DEVICE BATTERY HAD BEEN REPORTED TO BE COMPLETELY DEPLETED. OUR RECORDS INDICATE THAT THE DEVICE WAS EXPLANTED IN NOVEMBER, DUE TO NORMAL BATTERY DEPLETION, WITH A DEVICE STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS NOT RETURNED FOR RELIABILITY ANALYSIS. TO DATE, NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND A155

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R 0158| A155| 4470