BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI

    MDR report key: 3153529 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06068
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE OF 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: 5086MRI, IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING AT HIGH OUTPUT AND THE R WAVES HAD DIMINISHED. IT WAS ALSO REPORTED THAT MULTIPLE TESTS REVEALED A PERFORATION AND AN X-RAY SHOWED RV LEAD DISLODGEMENT. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256714 CAPSUREFIX MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R A3DR01 IMPLANTABLE PULSE GENERATOR