BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3041296 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01216
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    October 8, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT IT WAS NOT POSSIBLE TO INTERROGATE THE DEVICE AS THE BATTERY WAS DEPLETED. A NEW DEVICE WAS IMPLANTED AND THE OLD DEVICE WILL BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS RETURNED WITH THE DEVICE CASE SWOLLEN. ALL SEAL PLUGS WERE INTACT AND THE SETSCREWS MOVED FREELY. IT WAS CONFIRMED THAT THE DEVICE COULD NOT BE INTERROGATED AND HAD NO TELEMETRY. THE REASON FOR THE NO TELEMETRY WAS DUE TO A DEPLETED CELL. THE REASON FOR THE DEPLETED CELL COULD NOT BE DETERMINED AS A HIGH CORRECT DRAIN WAS NOT PRESENT DURING ANALYSIS. IT WAS OBSERVED THAT THE CELL VOLTAGE DROPPED AFTER IT WAS REMOVED FROM THE POWER SOURCE, HOWEVER ANALYSIS OF THE BATTERY CONCLUDED THAT THE CELL HAS NO DEFECTS THAT WOULD ACCOUNT FOR EARLY BATTERY DEPLETION. LABORATORY ANALYSIS ALSO NOTED THAT THERAPY WAS NOT AVAILABLE AT THE EXPLANT. LABORATORY ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS NOT POSSIBLE TO INTERROGATED THIS DEVICE. TROUBLESHOOTING WAS PERFORMED TO IDENTITY THE DEVICE ID UNDER X-RAY. TECHNICAL SERVICES WAS CONTACTED AND DISCUSSED TROUBLESHOOTING. IT WAS ALSO NOTED THAT PUTTING A MAGNET OVER THE DEVICE WAS NOT PRODUCING ANY BEEPING AND WHEN INDUCTING VERY LOW BRADYCARDIA NO PACING WAS SEEN. WITH THIS INFORMATION IT WAS SUSPECTED THAT THE BATTERY WAS DEPLETING. IT WAS NOTED THAT THE FIELD REPRESENTATIVE WILL PERFORM A COMPLETE INTERROGATION WITH MANUAL SOFTWARE INTERROGATION MODE AND WILL TRY TO CHANGE THE PROGRAMMER AND THE LOCATION OF INTERROGATION. UPON FURTHER INFORMATION THIS INVESTIGATION WILL BE UPDATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143913 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R