BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 4131760 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14857
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    December 29, 2009
    Report Date
    July 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RIGHT ATRIAL (RA) LEAD AND DEVICE DISPLAYED STEADILY INCREASING PACING IMPEDANCE MEASUREMENTS OVER A SIX YEAR PERIOD, ULTIMATELY REACHING GREATER THAN 2,500 OHMS. ADDITIONALLY, SUDDEN BRADYCARDIA RESPONSE (SBR) MAXIMUM RATE ACHIEVED WAS 125BPM, HOWEVER, THE ELECTROGRAM (EGM) DISPLAYED A RATE OF 300BPM THROUGH VISUAL INSPECTION. THE PATIENT LATER ENDURED OPEN HEART SURGERY FOR VALVE REPLACEMENT. FOLLOWING THE PROCEDURE, RA PACING IMPEDANCE MEASUREMENTS REMAINED GREATER THAN 2,500 OHMS, WITH DECREASED SENSING MEASUREMENTS. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME ADDITIONAL INFORMATION WAS NOT AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612219 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1294

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 4088| 1294| 4086