BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3991526 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08066
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. CONCOMITANT: 419688 LEAD IMPLANTED: 2011-(B)(6), 694765 LEAD IMPLANTED: 2003-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ALERT WAS TRIGGERED DUE TO RIGHT VENTRICULAR (RV) LEAD OVERSENSING FOR SHORT INTERVAL COUNTS (SIC) AND NON-SUSTAINED TACHYCARDIA (NST) EPISODES WITH LESS THAN 220 MS V-V INTERVALS. THE DOCTOR PLANNED ON REPLACED THE RV LEAD THAT DAY. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. THE RIGHT ATRIAL (RA) 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
    471332 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R D224TRK BIV ICD