BEUDAMED
    FDA Adverse Event Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1933695 · Received December 21, 2010

    Report

    Report Number
    2649622-2010-15349
    Date Received
    December 21, 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
    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) NO ANOMALIES FOUND. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. OUTER INSULATION COSMETIC DEPRESSION AND 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): NO ANOMALIES WERE FOUND. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED.

    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): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4): PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED FROM THE NURSING HOME, THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT'S HEALTH DECLINED SLOWLY AND STEADILY. THE PATIENT DIED IN THE NURSING HOME ON HOSPICE CARE FOR END STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CONGESTIVE HEART FAILURE, AND ALZHEIMER'S DISEASE. THE CAUSE OF DEATH WAS REPORTED AS ALZHEIMER'S DISEASE. THE PATIENT HAD A PHYSICIAN VISIT SEVENTEEN DAYS PRIOR TO DEATH AND THE DEVICE CHECK WAS NORMAL. THERE ARE NO ALLEGATIONS FROM A HEALTH CARE PROVIDER THAT THE DEATH WAS RELATED TO THE DEVICE AND/OR LEADS.

    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 Death