BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4160818 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11742
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONTINUATION: ADDRL1 IPG IMPLANTED: 2008-(B)(6); 1888T ST.JUDE LEAD IMPLANTED: 2008-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    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 INDICATED ATRIAL OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCE WITH POSSIBLE FRACTURE AND OVERSENSING ON THE ATRIAL CHANNEL. THE LEAD WAS EXPLANTED 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
    642141 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization| R 5076-58 LEAD