BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3993057 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09515
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 407652 LEAD, IMPLANTED 2005-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO FEELING SKIPPED HEART BEATS. THE RA LEAD TRIGGERED AN ALERT FOR LOW IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A LEAD WARNING WAS AGAIN TRIGGERED FOR THE RA LEAD DUE TO LOW PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD SHOWED INTERMITTENT UNDERSENSING. THE 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
    468600 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR