BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2032095 · Received March 28, 2011

    Report

    Report Number
    2649622-2011-04235
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    September 6, 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
    OH, 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS DISTORTED, OUTER INSULATION TORN, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS DISTORTED, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS DISTORTED, OUTER INSULATION TORN, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS DISTORTED, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED FOUR MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH THE CLINIC REPORTED THE PATIENT WAS 100% PACED AND HAD A MEDICAL HISTORY OF ATRIAL FIBRILLATION, MODERATE TRICUSPID VALVE REGURGITATION, AND PULMONARY HYPERTENSION.

    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 93 YR Death