BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2111204 · Received June 2, 2011

    Report

    Report Number
    2649622-2011-07707
    Event Type
    Death
    Date Received
    June 2, 2011
    Date of Event
    February 22, 2008
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL THE CONDUCTORS WERE STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL THE CONDUCTORS WERE STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. ANALYSIS OF THE DEVICE AND LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL THE CONDUCTORS WERE STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL THE CONDUCTORS WERE STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) AND TWO LEADS WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST THE IMPLANT OF THE RIGHT VENTRICULAR PACING LEAD.

    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 85 YR Death