BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831714 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05401
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    February 17, 2015
    Report Date
    March 4, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), A POWER ON RESET (POR) OCCURRED, AND HAD NO CAPTURE THE SAME DAY A MAGNETIC RESONANCE IMAGE (MRI) WAS TAKEN. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW IMPEDANCE AND NO CAPTURE. THE ICD WAS EXPLANTED AND REPLACED. THE RV 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
    375141 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 457445 LEAD, E2DR01AA IPG