BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1964294 · Received January 19, 2011

    Report

    Report Number
    2649622-2011-00078
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    December 24, 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. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION BREACHED CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 7 WEEKS AFTER DEVICE SYSTEM IMPLANT. THE DEATH CERTIFICATE NOTES THE CAUSE OF DEATH TO BE SUDDEN CARDIAC ARREST, CORONARY ARTERY DISEASE, ATHEROSCLEROTIC HEART DISEASE, AND DIABETES MELLITUS WITH CONTRIBUTING FACTORS OF HYPERTENSION AND CHRONIC RENAL FAILURE. FOLLOW UP DETERMINED PATIENT ADMITTED TO HOSPITAL SIX DAYS PRIOR TO DEATH WITH SEVERE CHEST PAIN WHILE UNDERGOING DIALYSIS. MYOCARDIAL INFARCTION RULED OUT. PATIENT IN PACED RHYTHM. CHEST XRAY NOTED PERSISTANT RIGHT PLEURAL EFFUSION. THE DAY PRIOR THE DEATH, SEVERE CHEST PAIN WITH ACUTE RESPIRATORY FAILURE REQUIRING INTUBATION. PATIENT SUBSEQUENTLY DETERIORATED AND CODE BLUE CALLED, BUT RESUSITATION WAS UNSUCCESSFUL. NO ALLEGATION OF ANY DEVICE/LEAD ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 7 WEEKS AFTER DEVICE SYSTEM IMPLANT. THE DEATH CERTIFICATE NOTES THE CAUSE OF DEATH TO BE SUDDEN CARDIAC ARREST, CORONARY ARTERY DISEASE, ATHEROSCLEROTIC HEART DISEASE, AND DIABETES MELLITUS WITH CONTRIBUTING FACTORS OF HYPERTENSION AND CHRONIC RENAL FAILURE. ADDITIONAL INFORMATION 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 60 YR Death