BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1864142 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16003
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT PRESENTED WITH SYMPTOMS OF NEAR SYNCOPE; UPON INTERROGATION, IT WAS NOTED THAT EVERYTHING TESTED FINE ON THE DEVICE. THE PATIENT HAS COMPLETE HEART BLOCK AND IS PACEMAKER DEPENDANT. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) STATED THAT HE WAS CALLED BACK TO THE CLINIC THE FOLLOWING DAY SINCE THE PATIENT EXPERIENCED AN ACTUAL EPISODE OF SYNCOPE. UPON INTERROGATION, ONE OF THE ELECTROGRAM STRIPS SHOWED A FIVE SECOND PAUSE DUE TO WHAT APPEARED TO BE NON-CAPTURE. HOWEVER, THERE WAS SOME THOUGHT THAT IT MAY HAVE BEEN OVERSENSING. NO NOISE WAS PRODUCED WHEN THE SR PERFORMED POCKET MANIPULATION AND ISOMETRICS. THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS ALSO REMAINED STABLE BETWEEN 450 AND 500 OHMS. IN AN ATTEMPT TO RESOLVE THE ISSUES, THE RV LEAD SENSITIVITY WAS PROGRAMMED TO 10MV AND THE DEVICE'S OUTPUT SET TO 5V AT 1.0MS, GIVING A LARGER SAFETY MARGIN SINCE THE LEAD'S THRESHOLD MEASUREMENT WAS ACTUALLY 1.2V. THIS REPROGRAMMING ATTEMPT WAS NOT SUCCESSFUL SO A LEAD REVISION PROCEDURE WAS SCHEDULED. DURING THE PROCEDURE, THE RV LEAD WAS EXPLANTED AND THE PHYSICIAN ALSO OPTED TO EXPLANT THE DEVICE SINCE IT HAD LESS THAN THREE YEARS LONGEVITY REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES STATED THAT IT IS UNCERTAIN IF THE ISSUES WERE CAUSED BY THE RV LEAD OR THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 4087| 4472| 1291| 4469