BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2151683 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06614
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO SEPSIS. UPON INTERROGATION IT WAS NOTED THAT THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASED IMPEDANCE MEASUREMENTS. LOSS OF VENTRICULAR CAPTURE WITH THREE SECOND PACING PAUSES WERE ALSO OBSERVED. IT WAS NOTED THAT THE PATIENT IS PACEMAKER DEPENDENT. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THE SYSTEM WAS NOT EXPLANTED AND THE PHYSICIAN BELIEVES THE VENTRICULAR LOSS OF CAPTURE WAS DUE TO AN ELECTROLYTE IMBALANCE. 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 1294

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L 5034| 1294| 4068| (B)(4)