BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2183563 · Received July 29, 2011

    Report

    Report Number
    2124215-2011-12771
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS INACTIVELY IMPLANTED. 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

    ADDITIONAL INFORMATION FROM THE LOCAL AREA SALES REPRESENTATIVE REPORTED THAT THE LOSS OF CAPTURE DID NOT RESULT IN ASYSTOLE. THE PATIENT WAS VENTRICULAR PACED 0%, THEREFORE, DID NOT RELY ON THE PACING FUNCTION OF THE LEAD. HOWEVER, THE PHYSICIAN CHOSE TO IMPLANT A NEW LEAD DURING THE GENERATOR CHANGE OUT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT VENTRICULAR (RV) LEAD DISPLAYED PACING IMPEDANCE MEASUREMENTS OF 1,100 OHMS, WITH INTERMITTENT CAPTURE AT 6.5 V @ 1MS. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    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 63 YR Hospitalization| R 1290| 4457| 4480| S606| 4136