BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 5282972 · Received December 9, 2015

    Report

    Report Number
    2649622-2015-14422
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    June 12, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT MEDICAL PRODUCTS: D314TRG ICD, IMPLANTED: (B)(6)2012. (B)(4).

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA OF THE LEAD WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. ATRIAL BIPOLAR PACING IMPEDANCE WAS LOW THROUGHOUT RECORD, RANGING FROM 133-304 OHMS. ATRIAL BIPOLAR LEAD IMPEDANCE WARNING OCCURRED ON (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS LOW PACING IMPEDANCE. INTERROGATION SHOWS THAT THE LEAD IMPEDANCE TREND WAS CHRONICALLY LOW. THE PHYSICIAN ELECTED TO LEAVE THE LEAD IN USE WITH NO INTERVENTION PERFORMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FURTHER INFORMATION INDICATES THAT THE RA LEAD IMPEDANCE WAS VARYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812422 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR