BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6007976 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-12654
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    July 30, 2016
    Report Date
    July 30, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: DTBA1D4 ICD, IMPLANTED: (B)(6) 2014; 6935M62 LEAD, IMPLANTED: (B)(6) 2014.

    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 PATIENT RECEIVED INAPPROPRIATE THERAPY FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD EXHIBITED UNDERSENSING. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654796 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 5071-53 X 2 LEAD