BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3991014 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08360
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE INNER INSULATION HAD A DEPRESSION BREACH.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING . THE ANALYST COMMENTED, ELECTRICAL CROSS CONTINUITY TEST RESULT WAS FAILED. PERFORMED DESTRUCTIVE ANALYSIS AND FOUND INNER INSULATION BREACHED IN -VIVO/ DEPRESSION. INSULATION BREACH DID CONTRIBUTE TO THE ELECTRICAL COMPLAINTS. CONCOMITANT MEDICAL PRODUCTS: 5086MRI58, LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD EXIT BLOCK, HIGH THRESHOLDS, AND INTERMITTENT PACING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470820 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 00057 YR Hospitalization| R