BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4160902 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11717
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 19, 2014
    Report Date
    July 19, 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
    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. CONCOMITANT MEDICAL PRODUCTS: A 5086MRI45 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MORNING FOLLOWING IMPLANT, THE RV (RIGHT VENTRICULAR) LEAD WAS CONFIRMED VIA X-RAY TO BE DISLODGED. LATER THAT DAY, LEAD PERFORATION THROUGH THE RIGHT VENTRICLE WAS ALSO NOTED. THE NEXT DAY THE LEAD WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE THE HELIX COULD NOT BE FULLY RELEASED FROM THE MYOCARDIAL TISSUE, AND ULTIMATELY A LASER SHEATH WAS USED FOR EXTRACTION. WHILE REATTACHING THE LEADS, AFTER MULTIPLE ATTEMPTS THE PHYSICIAN WAS UNABLE TO SCREW THE ATRIAL LEAD INTO THE HEADER. THE DEVICE 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
    642311 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 00067 YR Hospitalization| L| R A2DR01 IPG