BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2953345 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01061
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 22, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    DTB
    PMA / PMN Number
    P850089
    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 DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. IT WAS NOTED THAT IMPEDANCE FOR THE RIGHT ATRIAL (RA) LEAD WAS OUT OF RANGE LOW.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD SHOWED A LEAD WARNING IN THE TREND DATA. IT WAS NOTED THAT THE RA LEAD IMPEDANCE WAS LOW AND THERE WAS NO PACING OR SENSING TAKING PLACE. AN X-RAY CONFIRMED THAT THERE WAS A CLAVICLE RIB CRUSH OF THE RA LEAD. THE LEAD WAS PROGRAMMED OFF, AND WILL BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55501 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)