BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 5093971 · Received September 22, 2015

    Report

    Report Number
    2649622-2015-10659
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE ANALYST NOTED THAT THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED. TURNS TO EXTEND AND RETRACT HELIX WAS WITHIN SPECIFICATION.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR LEAD HELIX WAS NOT ABLE TO EXTEND WITHOUT AN EXCESSIVE NUMBER OF TURNS. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. 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
    625677 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 00081 YR