BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3992859 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09631
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT: PRODUCT ID 5086MRI52 LEAD IMPLANTED: 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION THE LEAD IMPEDANCE TREND GRAPH WAS NOT AVAILABLE. AT ONE CHECK, THE SETTINGS DID NOT ALLOW THE LEAD IMPEDANCE VALUE TO BE MANUALLY MEASURED. IT WAS SOLVED WHEN THE SETTINGS OF VENTRICULAR SENSING WAS CHANGED FROM BIPOLAR TO UNIPOLAR. IT WAS FURTHER REPORTED THAT AT THE LAST DEVICE CHECK, THE IMPEDANCE TREND DATA WAS AGAIN NOT RECORDED AND BOTH THE ATRIAL AND VENTRICULAR LEADS HAD HIGH IMPEDANCE. THE DEVICE AND LEADS REMAIN 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
    471544 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 00076 YR A3DR01 IPG