BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4162595 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12707
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 MEDICAL PRODUCTS: 693565 LEAD IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) FOR THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD DUE TO INCREASED SHORT INTERVAL COUNTS (SIC), OVERSENSING AND NOISE. THERE WAS POSSIBLE CROSSTALK OCCURRING WITH BOTH THE RV LEAD AND THE RIGHT ATRIAL (RA) LEAD. THE LEADS WERE REPROGRAMMED AND REMAIN 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
    644433 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention DDBB1D1 ICD