BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3993317 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09378
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. CONCOMITANT PRODUCT: RVDR01 IPG, IMPLANTED: (B)(6) 201. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LARGE DEFLECTIONS ON THE ATRIAL ELECTROGRAM THAT WERE DIFFICULT TO DETERMINE IF IT WAS NOISE OR FAR FIELD R-WAVE (FFRW) OVERSENSING. PATIENT MANIPULATION DID NOT RESULT IN NOISE. THE DEFLECTIONS WERE DETERMINED TO BE FFRW OVERSENSING. REPROGRAMMING WAS PERFORMED AND THE 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
    471379 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 00074 YR Required Intervention 5086MRI58 LEAD