BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953498 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01111
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE HAD "JUMPED" FROM 600 OHMS TO 900 OHMS AND THE THRESHOLD HAD INCREASED ASWELL. ONE VENTRICULAR HIGH RATE EPISODE (VHRE) WAS NOTED AND THERE WAS ALSO A VHRE FROM 5 MONTHS PRIOR THAT LOOKED LIKE NOISE. AT THAT TIME, THE SENSITIVITY WAS REPROGRAMMED AND AT THIS FOLLOW-UP, THE LEAD WAS REPROGRAMMED TO A UNIPOLAR PACING POLARITY. 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
    56635 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD