BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3210883 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07855
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    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 TWO CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. 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 BUILDUP 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.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THIS PATIENT HAD A COMPUTED TOMOGRAPHY SCAN (CT) SCAN APPROXIMATELY ONE MONTH AGO AND AGAIN YESTERDAY. THE MOST RECENT SCAN WAS DUE TO A SYNCOPAL EVENT WHICH RESULTED IN A FALL. THE PATIENT PRESENTED TO THE HOSPITAL DUE TO MULTIPLE SHOCKS. DEVICE INTERROGATION NOTED THAT ELECTIVE REPLACEMENT INDICATED (ERI) WAS OBSERVED AND THEN FIVE MINUTES LATER, END OF LIFE (EOL) WAS DECLARED AND THEN A FAULT CODE (FC) 01 WAS OBSERVED. THE PATIENT HAD RECEIVED MULTIPLE SHOCKS BEFORE AND AFTER THE CT SCAN WHICH ALL LOOK TO BE APPROPRIATE. NO NOISE WAS NOTED AND THE PATIENT WAS IN ATRIAL FIBRILLATION (AF). THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310133 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L 0125| 4269| 1821| 1763| 0049| 6835| T180| 1871