BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1874665 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11489
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 24, 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
    AZ, US
    Reporter Occupation
    OTHER

    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 DEVICE WAS ANALYZED WITH NO ANOMALIES FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED OVERSENSING. MULTIPLE NON-SUSTAINED TACHYARRHYTHMIA (NST) SENSED EVENTS OF LESS THAN 220MS BETWEEN (B)(6) 2008 AND (B)(6) 2009. ADDITIONAL NST SENSED EVENTS OF LESS THAN 220MS ON (B)(6) 2010, (B)(6) 2010, AND (B)(6) 2010. (B)(4) OUTER INSULATION BREACHED; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID ON PROXIMAL CONDUCTOR AND IN/ON HELIX MECHANISM. OUTER INSULATION BREACHED CUT. (B)(4) OUTER INSULATION BREACHED; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID ON PROXIMAL CONDUCTOR AND IN/ON HELIX MECHANISM. OUTER INSULATION BREACHED CUT. WHITE SUBSTANCE FOUND ON OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. IT WAS NOTED THAT THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING IN BOTH ATRIAL AND VENTRICULAR LEADS WHEN MANIPULATED AT POCKET AND THERE WAS A HIGH SENSING INTEGRITY COUNT. THE DEVICE AND LEADS WERE EXPLANTED 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 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R