BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161598 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11482
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATES OVERSENSING INFORMATION. IT WAS NOTED THAT THERE WAS ATRIAL TACHYCARDIA AND ATRIAL FIBRILLATION EPISODES RECORDED WITH APPARENT FAR-FIELD R-WAVE (FFRW) OVERSENSING. THERE WAS 67,807 ATRIAL SHORT INTERVAL COUNT (SIC) THAT HAD OCCURRED SINCE (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATES OVERSENSING INFORMATION. IT WAS NOTED THAT THERE WAS ATRIAL TACHYCARDIA AND ATRIAL FIBRILLATION EPISODES RECORDED WITH APPARENT FAR-FIELD R-WAVE (FFRW) OVERSENSING. THERE WAS 67,807 ATRIAL SHORT INTERVAL COUNT (SIC) THAT HAD OCCURRED SINCE 2014 (B)(6).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RA LEAD WAS FOUND TO BE OVERSENSING NOISE. THE LEAD WAS PROGRAMMED OFF AND REMAINS IN THE PATIENT, OUT OF SERVICE. THE LEAD WILL BE REMOVED AT A LATER DATE THAT HAS YET TO BE DETERMINED. A NEW LEAD WAS IMPLANTED FROM THE RIGHT SIDE OF THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS FAR-FIELD R-WAVE (FFRW) OVERSENSING WITH SEVERAL SHORT INTERVAL COUNTS (SIC) RESULTING IN FALSE MODE SWITCHING. THE ATRIAL SENSITIVITY ON THE LEAD WAS ADJUSTED TO PREVENT THE FFRW OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642035 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention P1501DR IPG, 5076-52 LEAD