BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2864934 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17587
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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. (B)(4). CONCOMITANT PRODUCT: 5086MRI IMPLANTABLE PACING LEAD (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED THAT THE VENTRICULAR LEAD APPEARED TO BE OVERSENSING THE T WAVE WHICH CAUSED VENTRICULAR TACHYCARDIA (VT) TO BE DETECTED. THE DEVICE HAD BEEN PROGRAMMED TO THE MANAGED VENTRICULAR PACING OPERATION AND THE EPISODE ALSO SHOWED A LOSS OF VENTRICULAR PACING RESULTING IN A BACKUP OF VENTRICULAR PACES OCCURRING ON THE T-WAVE. UNDERSENSING THE R WAVE WAS ALSO NOTED. 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
    1 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR RVDR01 IMPLANTABLE PULSE GENERATOR (IPG)