BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993229 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09437
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: PRODUCT ID P1501DR IPG, IMPLANTED: 2007-(B)(6); 5554-45 NON DEFIB LEAD IMPLANTED: 2007-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS 1,322 SHORT INTERVAL COUNTS (SIC) AND EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) WERE CONFIRMED TO BE NOISE. A POCKET MANIPULATION TEST WAS PERFORMED AND THE NOISE COULD NOT BE REPRODUCED. THE DOCTOR SCHEDULED THE NEXT DEVICE CHECK FOR 3 MONTHS AND IN THE MEANTIME WILL MONITOR THE PATIENT CLOSELY. THE PHYSICIAN SUSPECTS THAT THE LEAD HAS PARTIALLY DAMAGED. 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
    469088 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR