BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3401042 · Received October 10, 2013

    Report

    Report Number
    2649622-2013-11478
    Event Type
    Injury
    Date Received
    October 10, 2013
    Report Date
    July 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: (B)(4), IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, 2010 (B)(6); 0144, COMPETITIVE ICD LEAD, 2000 (B)(6); M7700-31, MECHANICAL VALVE, 1996 (B)(6); 1388T, COMPETITIVE PACING LEAD, 1998 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPERIENCING HIGH THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517080 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R