BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3513023 · Received December 10, 2013

    Report

    Report Number
    2649622-2013-15255
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    September 17, 2013
    Report Date
    September 17, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 DURING THE IMPLANT PROCEDURE AFTER THE PHYSICIAN ADVANCED AND THEN REPOSITIONED THE LEAD, THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. LATER DIAGNOSTICS SHOWED THAT THERE WAS A VENTRICULAR PERFORATION WHICH THE PHYSICIAN DECIDED TO TREAT MEDICALLY. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643964 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| L| R