BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1962277 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00946
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT INVESTIGATION IS ON-GOING AS A REQUEST WAS SENT TO THE FIELD REPRESENTATIVE FOR ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    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

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE'S TACHYCARDIA MODE HAD BEEN INADVERTENTLY DEACTIVATED ON (B)(6) 2010 AND THE PATIENT HAD BEEN LEFT UNPROTECTED UNTIL (B)(6) 2010 WHEN THE DEVICE'S TACHYCARDIA MODE WAS ENABLED AT THE CLINIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION ON DECEMBER 28, 2011 THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (V-TACHY MODE SET TO VALUE OTHER THAN MONITOR + THERAPY) ON (B)(6) 2010.THE LOCAL REPRESENTATIVE WAS CONTACTED. SUBSEQUENTLY, THE CLINIC NURSE CONTACTED TECHNICAL SERVICES TO DISCUSS THE ALERT. THE CLINIC NURSE WAS NOTIFIED THAT THE LATITUDE UPLOAD REPORTS THAT THE TACHYCARDIA MODE WAS OFF BUT THE LAST PROGRAMMED SETTING WAS MONITOR + THERAPY. THE PATIENT WAS SEEN IN-CLINIC ON (B)(6) 2010 WITH NO COMMENTS ALTHOUGH REPROGRAMMING WAS UNDERTAKEN ON (B)(6) 2010. TECHNICAL SERVICES RECOMMENDED THAT THE CLINIC HAVE THE PATIENT COME IN FOR A DEVICE CHECK. THE CLINIC NURSE WAS PLANNING TO CONTACT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening S603| 4470| 4457| 0158| E110