BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130051 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10089
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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 DISTAL SEGMENT WAS RETURNED AND ANALYSIS FOUND THE PROXIMAL CONDUCTOR WAS FRACTURED. THE OUTER TUBING WAS KINKED/BUCKLED WITH ENVIRONMENTAL STRESS CRACKING BREACH (NON-ELECTRICAL) AND THE OVERLAY WAS MELTED AND SHOWED COSMETIC ENVIRONMENTAL STRESS CRACKING. BLOOD WAS NOTED IN/ON THE HELIX/LOBE MECHANISM. (B)(4) THE DISTAL SEGMENT WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS NOTED ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED CUT WITH COSMETIC ENVIRONMENTAL STRESS CRACKING. BLOOD WAS NOTED IN/ON THE HELIX/LOBE MECHANISM. THERE WAS APPARENT EXPLANT DAMAGE NOTED. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS UNDERSENSING AND HAD HIGH THRESHOLD. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND DELIVERED INAPPROPRIATE THERAPY. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL LEAD WAS UNDERSENSING AND HAD HIGH THRESHOLD. BOTH LEADS WERE REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT SUBCLAVIAN VEIN WAS TOTALLY OCCLUDED AND THE RV LEAD EXHIBITED HIGH IMPEDANCE MEASUREMENTS. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB