BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2864834 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17613
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    February 1, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P920039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PRODUCT SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE TREND DATA SHOWS VENTRICULAR LEAD ALERT ON (B)(6) 2012. VENTRICULAR IMPEDANCE AT IMPLANT WAS 687 OHMS WITH A LIFETIME MAXIMUM IMPEDANCE OF 4336 TO 431 OHMS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD 2007 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD A LEAD WARNING AND IMPEDANCE THAT WAS HIGH AND HAD INCREASED SINCE IMPLANT, ALONG WITH HIGH THRESHOLD MEASUREMENTS WERE SIMILAR IN BOTH UNIPOLAR AND BIPOLAR. THE RIGHT VENTRICULAR (RV) 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
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)