BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3992866 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09619
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: 5086MRI58 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE TRANSMISSION WAS SENT DUE TO FUSION BEATS NOTED. THE TRANSMISSION SHOWED AN EPISODE OF VENTRICULAR UNDERSENSING RESULTING IN VENTRICULAR PACING. THERE WAS ALSO FAR FIELD R-WAVE OVERSENSING BY THE ATRIAL LEAD, RESULTING IN A MODE SWITCH. BOTH LEADS ARE STILL 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
    471289 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 00079 YR RVDR01 IPG