BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3994005 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09028
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED HIGH PACING IMPEDANCE. IT ROSE FROM 656 OHMS THE WEEK ENDING (B)(6) 2012 TO GREATER THAN 1000 OHMS THE WEEK ENDING (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 PRODUCT : 6947-65 LEAD IMPLANTED (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR TACHY LEAD HAD LOW R WAVES AND T WAVE OVERSENSING WAS OCCURRING. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED, AND THE HIGH VOLTAGE PORTION REMAINED IN USE. SUBSEQUENTLY, THE PACE/SENSE LEAD IMPEDANCE WAS NOTED TO HAVE STEADILY INCREASED SINCE IMPLANT TO 1100 OHMS, THE IMPEDANCE WAS HIGH AND A POSSIBLE FRACTURE WAS NOTED. THE PHYSICIAN USED THE LEAD ANALYZER TO CHECK THE SENSING ON THE TACHY LEAD, HOWEVER, THE R WAVES WERE STILL LOW. BOTH LEADS WERE 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
    471780 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Hospitalization| R 7232CX ICD