BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3071715 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05206
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WARNING AND POLARITY SWITCH OCCURRED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT THERE WERE A LARGE NUMBER OF VENTRICULAR HIGH RATE EPISODES (VHRE) WHICH LOOKED NON-PHYSIOLOGIC BUT THOUGHT THEY MAY HAVE BEEN FROM MYOPOTENTIAL 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
    171653 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR SESR01 IMPLANTABLE PULSE GENERATOR