BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2052177 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-05867
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING A CHARGE TIME OF 22.875 SECONDS AT A MONITORING VOLTAGE OF 2.54 VOLTS. END OF LIFE (EOL) WAS DECLARED WITH A SINGLE CHARGE TIME OF 30.26 SECONDS AT A MONITORING VOLTAGE OF 2.48 VOLTS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 3/10/2007 AND ALSO PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY APRIL 2007 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON 4/5/2007, HAD REACHED END OF LIFE (EOL) WITH A MONITORING VOLTAGE MEASUREMENT OF 2.46 VOLTS AND A CHARGE TIME MEASUREMENT OF 30.2 SECONDS. TH EVOLTAGE HAD GONE FROM 2.55 VOLTS TO 2.46 VOLTS WITHI THREE MONTHS WHICH APPEARED TO BE OUSTIDE NORMAL LIMITS. THE LOCAL AREA SALES REPRESENTATIVE DID INDICATE THAT THE PATIENT DOES PACE OFTEN AND THAT THIS CRT-D HAS BEEN IN SERVICE FOR OVER FIVE YEARS. THE TECHNICAL SERVICES CONSULTANT RECOMMENDED DEVICE CHANGE OUT AND RETURN FOR ANALYSIS. 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 T125

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention MISMATCH| 5568| 1861| T125| 0155