BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2202228 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11299
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STORED EVENTS SHOWING OVERSENSING IN THE ATRIAL AND VENTRICULAR CHANNEL. OVERSENSING WAS REPRODUCIBLE WITH POCKET MANIPULATION. DEVICE HEADER ISSUE WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. OVERSENSING CONTINUED AFTER DEVICE REPLACEMENT. THE POCKET WAS REOPENED AND SMALL INSULATION BREACHES WERE OBSERVED IN BOTH THE ATRIAL AND VENTRICULAR LEADS NEAR THE HEADER. THE VENTRICULAR LEAD WAS CAPPED AND REPLACED. THE ATRIAL LEAD REMAINS IN USE. THE PROBLEM WAS NOTED AS "RESOLVED" AT THIS TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB