BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 3160327 · Received June 10, 2013

    Report

    Report Number
    3008973940-2013-00094
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND. THE DISTAL LOW VOLTAGE ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY MELTED BUT NOT BREACHED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS. CONCOMITANT PRODUCT: 5086MRI IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED IN THE EMERGENCY WITH FAILURE TO CAPTURE ON THE RIGHT VENTRICULAR (RV) IMPLANTABLE PACING LEAD. POST IMPLANT, THE RV LEAD HAD DIMINISHED SENSING PLUS A MARGINAL INCREASE IN THE THRESHOLD. THE DECISION WAS MADE TO MONITOR THE PATIENT. SUBSEQUENTLY, THE RV LEAD THRESHOLDS WERE UNSTABLE AND FAILING TO CAPTURE. 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
    259700 CAPSUREFIX NOVUS MRI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC SINGAPORE OPERATIONS 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R A3DR01, IMPLANTABLE PULSE GENERATOR