BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3990135 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08807
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTEMPTED RIGHT VENTRICULAR (RV) LEAD WAS DIFFICULT TO FIXATE AND EXHIBITED SUBOPTIMAL SENSING FUNCTION. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465021 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR MCS-P3-29-AOA AORTIC VALVE