BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2791096 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15402
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ANALYZED. THE INNER INSULATION HAD BREACHED METAL ION OXIDATION. THERE WAS BLOOD ON THE ELECTRODE - TIP ELECTRODE. THE DISTAL AND PROXIMAL CONDUCTORS WERE DISTORTED. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. THE INNER INSULATION WAS KINKED BUCKLED. THE OUTER INSULATION WAS PULLED APART (OVERSTRESS). THE INNER AND OUTER INSULATION HAD COSMETIC METAL ION OXIDATION. THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING ON THE OUTER INSULATION. IT WAS ALSO NOTED THE OUTER INSULATION WAS TORN, BREACHED CUT AND HAD A WHITE SUBSTANCE. EVALUATION SUMMARY (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION AND COSMETIC ENVIRONMENTAL STRESS CRACKING ALONG WITH A WHITE SUBSTANCE. THERE WAS ALSO A COSMETIC DEPRESSION ON THE OUTER INSULATION. VISUAL ANALYSIS REVEALED THERE WAS APPARENT EXPLANT DAMAGE. IT WAS NOTED THAT VISUAL ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL LEAD (RA) DEMONSTRATED LOW IMPEDANCE MEASUREMENTS, FAILURE TO SENSE, HIGH THRESHOLD, AND FAILURE TO CAPTURE. DURING EXTRACTION OF THE RA LEAD, THE RIGHT VENTRICULAR (RV) LEAD PERFORATED THE VENTRICLE RESULTING IN AN EMERGENCY THORACOTOMY. THE ENTIRE SYSTEM WAS REMOVED AND A NEW DEVICE AND LEADS WERE IMPLANTED. 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 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R SEDR01 IMPLANTABLE PULSE GENERATOR