BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3153153 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05840
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. CONCOMITANT PRODUCTS: E2DR21P IMPLANTABLE PULSE GENERATOR, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WOULD NOT CAPTURE OR SENSE IN BIPOLAR MODE, BUT WOULD IN UNIPOLAR. THE UNIPOLAR IMPEDANCE IS ALSO LOW. THE LEAD WAS NOT REPLACED AND IS STILL 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
    256107 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR 4068 IMPLANTABLE PACING LEAD