BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4500387 · Received February 10, 2015

    Report

    Report Number
    2649622-2015-00987
    Event Type
    Injury
    Date Received
    February 10, 2015
    Date of Event
    July 9, 2014
    Report Date
    December 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. WEEKLY IMPEDANCE TREND SHOWS ATRIAL LEAD IMPEDANCE SPIKED FROM A BASELINE OF APPROXIMATELY 600 OHMS TO GREATER THAN 9999 OHMS WEEK OF 2014-JUL-11 AND REMAINED OUT OF RANGE/UNDEFINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: 5076-58 LEAD 2008-(B)(6). (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE AND FREQUENT ATRIAL EPISODES. THE VERIFIED EPISODES INDICATED THAT THEY MIGHT BE TRIGGERED BY A FRACTURE. NOISE WAS NOT REPRODUCED WHILE HAVING THE PATIENT SWING HIS ARMS AROUND, POCKET MANIPULATION TEST, BUT OVERSENSING OF THE MYOGENIC POTENTIAL WAS CONFIRMED WHILE PRESSING HANDS TOGETHER. THE DEVICE WAS REPROGRAMMED AND 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
    94214 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention P1501DR IPG