BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2953120 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00896
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    July 17, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 CONTINUED: 4592 IMPLANTABLE PACING LEAD (B)(6) 2002.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED WITH STEADILY INCREASING IMPEDANCE. THERE WAS HIGH IMPEDANCE ON BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE LEAD WAS PROGRAMMED UNIPOLAR AND IT 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
    55751 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 00100 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR