BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3860124 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05565
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PRODUCT: 5086MRI LEAD IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN A WEEK OF IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF CHEST PAIN. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE AT MAXIMUM OUTPUTS AS WELL AS UNDERSENSING WHILE IN THE BIPOLAR CONFIGURATION. THE RV LEAD ALSO EXHIBITED UNSTABLE IMPEDANCES. THE LEAD WAS FOUND TO HAVE MIGRATED THROUGH THE APEX OF THE HEART, RESULTING IN A PERFORATION. THE LEAD WAS REPOSITIONED AND 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
    337206 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 00065 YR Hospitalization| L| R A2DR01 IPG