BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2053040 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04898
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS MEDICAL PERSON CALLED TECHNICAL SERVICES (TS) INQUIRING ABOUT THE LONGEVITY REMAINING WITH THIS PACEMAKER. SHE REPORTS THAT TODAY, THE DEVICE IS DISPLAYING 2.5 YEARS REMAINING, HOWEVER SIX MONTHS PRIOR IT DISPLAYED 4 YEARS REMAINING. THE CALLER STATES THE PATIENT HAS HIGH RIGHT VENTRICULAR THRESHOLDS, BUT IS NOT PACED IN THE VENTRICLE AND 67 PERCENT PACED IN THE ATRIUM. TS DISCUSSED WHAT INFORMATION IS USED TO DETERMINE LONGEVITY CALCULATIONS AND ASKED IF ANYTHING HAD CHANGED WITH DEVICE PROGRAMMING OR PARAMETERS. THE CALLER STATED THE PATIENT HAD AUTO CAPTURE ON AND WAS PACING IN RETRY. TS DISCUSSED THIS COULD BE THE REASON FOR THE LONGEVITY CHANGE AND OFFERED TO DO A MEMORY DOWNLOAD FROM THE DEVICE, BUT THE CALLER DECLINED AND STATED SHE WOULD SEE THE PATIENT AGAIN IN 3 MONTHS AND EVALUATE AGAIN AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4243| 4034| 1290| 1274