BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1780414 · Received August 3, 2010

    Report

    Report Number
    2649622-2010-06898
    Event Type
    Death
    Date Received
    August 3, 2010
    Date of Event
    May 14, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. ANALYSIS SUMMARY - (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND. DISTAL CONDUCTOR DISTORTED, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER INSULATION BREACHED CUT, OUTER TUBING OVERLAY BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED. PROXIMAL CONDUCTOR DISTORTED AND FLATTENED WITH BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION BREACHED CUT, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY - (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR DISTORTED, SEVERAL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER INSULATION BREACHED CUT, OUTER TUBING OVERLAY BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, PROXIMAL CONDUCTOR DISTORTED AND FLATTENED WITH BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION BREACHED CUT, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED. CORRECTION TO DEVICE CONCLUSION CODE ((B)(4) ).

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SEVERE HEART FAILURE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PATIENT HAD AN ICD IMPLANTED AND EXPERIENCED NO COMPLICATIONS. PULMONARY REHABILITATION WAS PLANNED AND THE PATIENT WAS SENT HOME. IT WAS LATER REVEALED THE PATIENT COLLAPSED AT HOME APPROXIMATELY 5 WEEKS LATER IN VENTRICULAR FIBRILLATION. PARAMEDICS ATTEMPTED EXTERNAL DEFIBRILLATION 5 TIMES AND THEN STOPPED CPR DUE TO PULSELESS ELECTRICAL ACTIVITY. THE PATIENT DIED (B)(6) 2009. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SEVERE HEART FAILURE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PATIENT HAD AN ICD IMPLANTED AND EXPERIENCED NO COMPLICATIONS. PULMONARY REHABILITATION WAS PLANNED AND THE PATIENT WAS SENT HOME. IT WAS LATER REVEALED THE PATIENT COLLAPSED AT HOME APPROXIMATELY 5 WEEKS LATER IN VENTRICULAR FIBRILLATION. PARAMEDICS ATTEMPTED EXTERNAL DEFIBRILLATION 5 TIMES AND THEN STOPPED CPR DUE TO PULSELESS ELECTRICAL ACTIVITY. THE PATIENT DIED (B)(6) 2009. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS LATER REPORTED PATIENT WAS NOT PACEMAKER DEPENDENT AND THE LAST CLINIC VISIT HAD BEEN (B)(6) 2009.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD| 4076 IMPLANTABLE PACING LEAD