BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861334 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07313
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S 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: E2DR01 IPG IMPLANTED: UNKNOWN . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RHYTHM WAS 45 BEATS PER MINUTE. INTERROGATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) INDICATED THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS LOW, AND A THRESHOLD TEST RESULTED IN LOSS OF CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED. WHEN THE RV LEAD WAS CONNECTED TO THE NEW IPG, THE IMPEDANCES AND THRESHOLDS WERE IN RANGE. THE PHYSICIAN WONDERED WHY THE DEVICE INDICATED ELECTIVE REPLACEMENT INDICATOR (ERI) INSTEAD OF END OF LIFE (EOL). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336912 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Life Threatening 1388T ST JUDE LEAD