BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1950867 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22807
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, THE DEVICE AND VENTRICULAR LEAD REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    TWO MONTHS LATER THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE HAS NOT BEEN RETURNED TO THIS DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS OVERSENSING RESULTING IN PACING INHIBITION. THE PATIENT'S RATES WERE IN THE 30 BPM RANGE. THE PATIENT IS PACEMAKER DEPENDENT AND WAS SYMPTOMATIC AT THESE LOW RATES. THE SALES REPRESENTATIVE NOTED SHE WOULD TRY A FEW THINGS TO MITIGATE THIS ISSUE AND WOULD CALL BACK SHOULD SHE REQUIRE FURTHER TROUBLESHOOTING FROM TECHNICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening 1298| 4086| 4034