BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1912171 · Received December 2, 2010

    Report

    Report Number
    2649622-2010-12182
    Event Type
    Death
    Date Received
    December 2, 2010
    Date of Event
    October 19, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. (B)(4) PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. ALL CONDUCTORS STRETCHED, OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. PROXIMAL CONDUCTOR STRETCHED, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS PERFORMED ONLY. (B)(4) PROXIMAL SEGMENT OF THE LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND. ALL CONDUCTORS STRETCHED, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, 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 WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS STRETCHED, OUTER INSULATION BREACHED CUT AND COSMETIC DEPRESSION, AND VISUAL ANALYSIS WAS PERFORMED. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. PROXIMAL CONDUCTOR STRETCHED, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS WAS PERFORMED. (B)(4) PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS STRETCHED, OUTER INSULATION COSMETIC DEPRESSION, APPARENT EXPLANT DAMAGE, AND VISUAL ANALYSIS WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER DEVICE AND LEAD REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, THE PATIENT DECLINED AGGRESSIVE TREATMENT IN THE HOSPITAL AND WAS ADMITTED INTO HOSPICE CARE WITH A DIAGNOSIS OF CONGESTIVE HEART FAILURE. THE PATIENT WAS DYSPNEIC AND DISTRESSED. IMPLANTABLE CARDIOVERTOR DEFIBRILLATOR THERAPIES WERE TURNED OFF TEN DAYS PRIOR TO THE PATIENT'S DEATH. PACEMAKER THERAPIES REMAINED ON. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE PATIENT'S DEATH WAS DEVICE AND/OR LEAD RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2009 APPROXIMATELY FOUR MONTHS AFTER DEVICE AND LEAD REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 82 YR Death