BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4499184 · Received February 10, 2015

    Report

    Report Number
    2649622-2015-01578
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    November 26, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: ADDR01 IPG IMPLANTED: 2011-(B)(6). (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DATA INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. AVERAGE WEEKLY ATRIAL LEAD IMPEDANCE RANGED FROM 821-1212 OHMS THROUGHOUT THE RECORD, WITH A MAXIMUM RECORDED IMPEDANCE OF 1248 OHMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD SHOWED HIGH IMPEDANCE AND LOSS OF CAPTURE. SINUS EXIT BLOCK OR CONDUCTOR FRACTURE WERE SUSPECTED. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95305 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 4092-58 LEAD