BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2201863 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11213
    Event Type
    Injury
    Date Received
    August 11, 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
    MN, 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 IN SEGMENTS AND PRIMARY ANALYSIS REVEALED NO ANOMALIES. THE DEFIBRILLATION COIL WAS DISTORTED AND SEVERAL CONDUCTORS WERE CUT. THE OUTER TUBING OVERLAY WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKS (ESC), AND ESC BREACH/BREACH (NON-ELECTRICAL). ALL INSULATORS WERE BREACHED CUT INCLUDING THE INNER INSULATION. THE OUTER INSULATION ALSO HAD A COSMETIC DEPRESSION. THERE WAS BLOOD PRESENT IN/ON THE HELIX/LOBE MECHANISM. THERE WAS ALSO APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD SHOWED HIGH THRESHOLDS. THE LEAD WAS REMOVED AND REPLACED. 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 66 YR Hospitalization| R 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD