BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2012-14226

    MDR report key: 2908661 · Received January 10, 2013

    Report

    Report Number
    2124215-2012-14226
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE , THE FIELD REPRESENTATIVE FOLLOWED UP WITH THE PATIENT AND SHOCK IMPEDANCE VALUES WERE NORMAL AND MATCHED THE DAILY MEASUREMENTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS AGAIN CONTACTED TO REVIEW THE DAILY MEASUREMENTS OF THIS PATIENT. TS FELT THAT MOST LIKELY THE REASON FOR THE RISE IN SHOCK IMPEDANCES GREATER THAN 125 OHMS WAS ENVIRONMENTAL INTERFERENCE. THE TREND SINCE IMPLANT HAS BEEN STABLE. THERE WERE NO EPISODES WHICH SUGGEST INAPPROPRIATE SENSING (SEPARATE RATE/SENSE LEAD), AND THE ONLY ONE COMMANDED MEASUREMENT IN THE CLINIC WAS OUT OF RANGE. THE AGENT SUGGESTED THE FIELD REPRESENTATIVE COULD PERFORM ISOMETRIC TESTING DURING SHOCK TESTS TO LOOK FOR IMPEDANCE FLUCTUATIONS. THE FIELD REPRESENTATIVE ADVISED TS THAT AN X-RAY MAYBE PERFORMED IN THE NEAR FUTURE TO CHECK THE INTEGRITY OF THE LEAD AND RULE OUT INSULATION DAMAGE OR A LEAD FRACTURE. TS ADVISED FIELD REPRESENTATIVE THAT ELECTROGRAM (EGM) CHANNELS WERE CLEAN . AT THIS TIME NO REVISION HAS BEEN PERFORMED AND THE DEVICE AND LEAD REMAIN IN SERVICE. THE PHYSICIAN IS AWARE OF THE SITUATION AND THE PATIENT WILL BE MONITORED CLOSELY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD REVEALED NORMAL SHOCK AND IMPEDANCE MEASUREMENTS DURING SHOCK IMPEDANCE TESTING. WHEN A SHOCK INTEGRITY TEST WAS PERFORMED THE DEVICE AND LEAD EXHIBITED HIGH SHOCK IMPEDANCES GREATER THAN 125 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED DUE TO THE SUDDEN RISE IN SHOCK IMPEDANCES. THE AGENT ADVISED TO MONITOR THE SYSTEMS PERFORMANCE AND REVIEW THE MOST CURRENTLY DAILY MEASUREMENTS OF THIS PATIENT FOR A TREND IN THE SHOCK IMPEDANCES. THE FIELD REPRESENTATIVE WILL FOLLOW UP WITH THE PATIENT AT A LATER DATE TO REVIEW. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13425 DTB GUIDANT PUERTO RICO BV

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L 4471| 1190| 4457| 1180