BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2173823 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10789
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR LEAD EXPERIENCED NOISE AND OVERSENSING DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). THIS RESULTED IN PACING INHIBITION AND ASYSTOLE FOR GREATER THAN TWO SECONDS FOR THIS PATIENT. THE DEVICE WAS EXPLANTED AS IT ONLY HAD TWO YEARS OF REMAINING LONGEVITY. THE RV LEAD WAS ALSO EXPLANTED. A NEW RV LEAD AND DEVICE WERE SUCCESSFULLY IMPLANTED. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1198

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R MISMATCH| 4137| S401| 4024| 1198