BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1072511 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03718
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    October 2, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: PKF725776S NO ANOMALIES WERE FOUND. EVALUATION SUMMARY: NO ANOMALIES FOUND; FULL LEAD RETURNED FOR ANALYSIS. EVALUATION SUMMARY: NO ANOMALIES FOUND; DISTAL SEGMENT RETURNED FOR ANALYSIS. IT WAS REPORTED THE PATIENT FELL ON THEIR LEFT SHOULDER AND SHORTLY THERE AFTER HEART RATE WAS NOTED AS 40 BPM. IT WAS FOUND THAT THE LV 4193 LEAD HAD NO CAPTURE, THE RV 4068 LEAD HAD RISEN IN CAPTURE THRESHOLD AND THE DEVICE EXHIBITED SENSING DIFFICULTIES. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED MECHANICAL TESTS PERFORMED VISUAL EXAMINATION DEVICE PERFORMED ACCORDING TO SPECIFICATIONS NO CONCLUSION CAN BE DRAWN HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON THEIR LEFT SHOULDER AND SHORTLY THERE AFTER HEART RATE WAS NOTED AS 40 BPM. IT WAS FOUND THAT THE LV 4193 LEAD HAD NO CAPTURE, THE RV 4068 LEAD HAD RISEN IN CAPTURE THRESHOLD AND THE DEVICE EXHIBITED SENSING DIFFICULTIES. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention