BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3160421 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07984
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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 THE PATIENT WAS EXPERIENCING NEAR SYNCOPAL EPISODES. DURING INTERROGATION, FAR FIELD OVERSENSING OF THE RIGHTA TRIAL (RA) LEAD WAS FOUND. PROGRAMMING CHANGES WERE MADE AND THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260277 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC PUERTO RICO 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RVDR01 IMPLANTABLE PULSE GENERATOR (IPG)