BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-07279

    MDR report key: 2070218 · Received April 27, 2011

    Report

    Report Number
    2124215-2011-07279
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    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 IN SERVICE. 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 PHYSICIAN NOTED A CHECK LV LEAD STATEMENT ON THE PROGRAMMER. THE LEAD DISPLAYED OUT OF RANGE IMPEDANCE MEASUREMENTS OR LOW INTRINSIC AMPLITUDE MEASUREMENTS. THE PHYSICIAN INFORMED OUR REPRESENTATIVE OF THE STATEMENT NOTED; HOWEVER, THE SPECIFIC LEFT VENTRICULAR LEAD MODEL AND SERIAL WERE NOT PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1