BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 4831235 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05645
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 23, 2015
    Report Date
    September 2, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE HELIX OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ADDRL1 IPG, IMPLANTED: (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS, HIGH IMPEDANCE, A POSSIBLE FRACTURE, AND WAS OVERSENSING NOISE. MULTIPLE MODE SWITCH EPISODES WERE NOTED WITH THE NOISE. THE PROBLEMS WITH THE RA LEAD WERE DISCOVERED DURING A REMOTE MONITORING DIAGNOSTIC REPORT. THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT TO FURTHER INVESTIGATE THE RA LEAD. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RA FRACTURE WAS CONFIRMED JUST DISTAL TO THE TIE-DOWN SLEEVE. THE RA LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374416 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Hospitalization| R