BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3860762 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05299
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 PRODUCT: KDR901, IMPLANTABLE PULSE GENERATOR (IPG), (B)(6) 2005; 4951M-35, IMPLANTABLE PACING LEAD, (B)(6) 2005; 5071-53, IMPLANTABLE PACING LEAD, (B)(6) 2005; 5071-53, IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD A CONFIRMED FRACTURE, EXHIBITED HIGH IMPEDANCE AND WAS EXPLANTED AND REPLACED. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE A CONFIRMED FRACTURE, HIGH IMPEDANCE, AND NOISE. IN ADDITION, TWO LEFT VENTRICULAR (LV) LEADS WERE PARTIALLY EXPLANTED DUE TO NO CAPTURE AND HIGH IMPEDANCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337291 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R 5568-53 IMPLANTABLE PACING LEAD