BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1922346 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12877
    Event Type
    Injury
    Date Received
    December 13, 2010
    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
    FL, 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) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD IN/ON HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS ABANDONED DUE TO A HIGH/UNSTABLE THRESHOLD, AND APPARENT LEAD CONDUCTOR FRACTURE BASED ON HIGH IMPEDANCE (GREATER THAN 3000 OHMS). AN ATTEMPT WAS MADE TO IMPLANT ANOTHER ATRIAL LEAD, BUT THE LEAD WAS TOO SHORT. ANOTHER NEW ATRIAL 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 82 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB