BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 3904186 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10609
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    August 23, 2013
    Report Date
    July 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE ATTEMPTS TO REQUEST FOR THE RETURN OF THIS DEVICE WERE UNSUCCESSFUL AND THIS PRODUCT WAS NEVER RETURNED FROM THE FIELD 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 AND/OR THE DEVICE EVENTUALLY GET RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS OVERSENSED NOISE NOTED INVOLVING THIS PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO VENTRICULAR PAUSES CAUSED BY PACING INHIBITION DUE TO THE OVERSENSING. THE DEVICE WAS ALSO FOUND TO BE AT END OF LIFE (EOL) BUT THERE ARE NO ALLEGATIONS AGAINST THE BATTERY PERFORMANCE. THE PHYSICIAN ELECTED TO DO A COMMANDED SHOCK TO TEST THE SYSTEM, WHICH WAS SUCCESSFUL AND YIELDED A NORMAL SHOCK IMPEDANCE. DURING THE CHANGE OUT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY UNTIGHTENING THE SETSCREWS IN THE HEADER AND DAMAGE WAS SEEN TO HAVE OCCURRED AROUND THE IS1 CONNECTOR ON THE RV LEAD AS FORCE WAS APPLIED TO REMOVE THE LEAD. THE PHYSICIAN ELECTED TO REPLACE THE WHOLE SYSTEM AND THE RV LEAD WAS SURGICALLY ABANDONED, WHILE THE DEVICE WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REVEALED THAT THE PATIENT ORIGINALLY CAME INTO THE CLINIC TO HAVE THEIR DEVICE CHECKED AS THEIR ICD HAD BEEN BEEPING DUE TO THE BATTERY BEING AT EOL. AGAIN, NO ALLEGATIONS WERE MADE AGAINST THE BATTERY AND THE PATIENT WAS JUST INQUIRING ABOUT ITS CURRENT STATUS DUE TO THE TONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382978 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1871

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR 1871| 0155