BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3861120 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07361
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 IN SEGMENTS, ANALYZED AND THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN INADVERTENTLY CUT THE RIGHT ATRIAL (RA) LEAD BY ACCIDENT PRIOR TO IMPLANT. THE REPLACEMENT RIGHT ATRIAL (RA) LEAD WAS DAMAGED WHILE BEING INSERTED IN THE LEFT AXILLARY VEIN. THE IMPEDANCE READING THROUGH THE ANALYZER WAS LESS THAN 200 OHMS. A DIFFERENT RA LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340028 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 00080 YR