BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3992292 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09969
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND DID NOT HAVE CAPTURE. THE LEAD WAS REPOSITIONED AND 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
    471841 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 00071 YR Hospitalization| R A2DR01 IPG