BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2201909 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11236
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), AND THE PROXIMAL CONDUCTOR APPEARED DISTORTED. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM. THE OUTER INSULATION WAS BREACHED CUT, AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE IMPLANT ATTEMPT, REPRODUCIBLE NOISE WAS SEEN THROUGH THE DEVICE WHEN WIGGLING THE SUTURE SLEEVE. THE LEAD WAS THOUGHT TO BE FRACTURED. THE LEAD WAS NOT USED, AND A NEW LEAD WAS IMPLANTED. NO 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other