BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812496 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17436
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DISTAL END OF THE ELECTRODES WERE COVERED IN BLOOD AND BODY TISSUE/FIBROTIC GROWTH WAS PRESENT. THE OUTER INSULATION HAD A COSMETIC DEPRESSION. DISTAL CONDUCTORS WERE DISTORTED KINKED/BUCKLED, NOT OBSTRUCTED, BUT THERE WAS BLOOD PRESENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POCKET INFECTION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED, HAD HIGH IMPEDANCE, AND THERE WAS NO CAPTURE AT MAXIMUM OUPUT. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN 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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R