BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2051632 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05608
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 18, 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
    SC, 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) OUTER INSULATION BREACHED CUT. ADDITIONAL FINDINGS INCLUDED BLOOD IN/ON HELIX MECHANISM AND DAMAGED AT IMPLANT. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED AT IMPLANT ATTEMPT OF THE LEAD THAT THE PHYSICIAN FELT HE HAD CUT THE LEAD WITH THE SCALPEL WHEN CUTTING THE SUTURE SLEEVE. IT WAS FURTHER REPORTED THE PHYSICIAN AND MANUFACTURER REPRESENTATIVE SAW A SMALL NICK IN LEAD. A NEW LEAD WAS IMPLANTED. 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 81 YR Other