BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1792405 · Received August 11, 2010

    Report

    Report Number
    2649622-2010-07100
    Event Type
    Injury
    Date Received
    August 11, 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
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE 6949 LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. EVALUATION SUMMARY: (B)(4) PRIMARY ANALYSIS FINDING: NO ANOMALIES WERE FOUND. (B)(4) PRIMARY ANALYSIS FINDING: NO ANOMALIES WERE FOUND. THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD, OUTER INSULATION BREACHED CUT, BLOOD ON HELIX. EVALUATION SUMMARY: (B)(4) PRIMARY ANALYSIS FINDING: PROXIMAL CONDUCTOR FRACTURED. BLOOD/BODY FLUID WAS PRESENT ON THE HELIX MECHANISM. THE DEFIB CONDUCTOR WAS OBSERVED TO BE DISTORTED. THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE 6949 LEAD MODEL IS INCLUDED IN A FIELD ADVISORY. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND. (B)(4) NO ANOMALIES FOUND. THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD, OUTER INSULATION BREACHED CUT, BLOOD ON HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING A CARDIAC ARREST. UPON DEVICE INTERROGATION, T-WAVE OVERSENSING WAS OBSERVED. ADDITIONAL INFORMATION RECEIVED REPORTED THE ENTIRE ICD SYSTEM (LEADS AND DEFIBRILLATOR) WAS REMOVED DUE TO ENDOCARDITIS. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention