BEUDAMED
    FDA Adverse Event Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1865028 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10867
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LEADS 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): NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD IN/ON HELIX MECHANISM. (B)(4): NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID IN/ON PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND HELIX MECHANISM. OUTER INSULATION BREACHED CUT. APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND VENTRICLE ACTIVE FIX LEADS WERE EXTRACTED DUE TO PERFORATION IN THE RIGHT VENTRICLE WITH PERICARDIAL EFFUSION. THE VENTRICLE LEAD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD WAS EXPLANTED BUT NOT REPLACED. 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 ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ADDRL1 IMPLANTABLE PULSE GENERATOR| ADDRL1 IMPLANTABLE PULSE GENERATOR