BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3992531 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09825
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 10, 2013
    Report Date
    May 6, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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: MODEL: 5086MRI45, LEAD; IMPLANT: 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEIR RIGHT VENTRICULAR (RV) LEAD HAD PERFORATED THE HEART. FOLLOW-UP WITH THE CLINIC REVEALED THE PATIENT EXPERIENCED A "LATE MICROPERFORATION WITH PERICARDITIS" AND "MINIMAL PERICARDIAL EFFUSION." THE LEAD WAS REPOSITIONED, THE PATIENT WAS OBSERVED, AND NO FURTHER TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472210 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| L| R A2DR01, IPG