BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3990488 · Received August 8, 2014

    Report

    Report Number
    3008973940-2014-00278
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 457453 LEAD, IMPLANTED: (B)(6) 2014, PRODUCT EVENT. SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY IMPLANTED AND THE PATIENT EXPERIENCED AN INCREASE OF SINUS TACHY DURING THE PROCEDURE. THE FOLLOWING DAY THE RV LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS REPOSITIONED, PROGRAM ADJUSTMENTS WERE MADE AND LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE RANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467441 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R A3DR01 IPG