BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1902782 · Received November 18, 2010

    Report

    Report Number
    2649622-2010-12100
    Event Type
    Death
    Date Received
    November 18, 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
    NJ, 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. ANALYSIS OF THE DEVICE 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) 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 CONDUCTORS WERE STRETCHED, THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL ANALYSIS PERFORMED ONLY.

    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 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 CONDUCTORS WERE STRETCHED, THE OUTER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED AND THE DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED THE PATIENT HAD BEEN IN AN ASSISTED CARE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED AND THE DATE OF DEATH IS UNKNOWN. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 87 YR Death