BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3862279 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06993
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DURING AN IMPLANT PROCEDURE, RIGHT VENTRICULAR (RV) PACING THRESHOLDS WERE OBSERVED TO BE WITHIN A NORMAL RANGE. IT WAS FURTHER REPORTED THAT AFTER THE PATIENT'S INCISION WAS SUTURED, PACING MEASUREMENTS WERE RE-CHECKED, AND HIGH THRESHOLDS WERE OBSERVED ON THE RV LEAD. THE INCISION WAS REOPENED, AND THE RV LEAD REPOSITIONED. FINAL MEASUREMENTS WERE OBTAINED INDICATING THAT PACING THRESHOLDS RETURNED TO NORMAL VALUES. THE PHYSICIAN EXPRESSED THAT THE CHANGE IN THRESHOLDS MAY HAVE BEEN DUE TO EXIT BLOCK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337727 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 00084 YR Hospitalization| R A2DR01 IPG