BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3861142 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07387
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED STRETCHING. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, THE GUIDE TOOTH OF THE LEAD WAS EXTRINSICALLY DAMAGED, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE ANALYST NOTED THAT THE LEAD RETURNED STRETCHED AND WITH THE HELIX FULLY EXTENDED. THE HELIX CANNOT BE RETRACTED DUE TO SEVERE DAMAGE THAT OCCURRED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT ATRIAL (RA) LEAD THE HELIX WOULD NOT EXTEND AFTER MORE THAN 30 TURNS. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341888 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR