BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1913392 · Received December 3, 2010

    Report

    Report Number
    2649622-2010-12205
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    September 18, 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
    WA, 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, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. 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. (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC DEPRESSION. 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 COLLAPSED AT A FOOTBALL GAME. "WAS IN PEA IN EMERGENCY ROOM." THE PATIENT IS REPORTED TO HAVE DIED. NO DEVICE PROBLEMS HAD BEEN REPORTED. THE PATIENT HAD BEEN PACEMAKER DEPENDENT. FOLLOW UP WITH PHYSICIAN REVEALED CAUSE OF DEATH WAS SUDDEN UNEXPLAINED DEATH, PRESUMED SUDDEN CARDIAC DEATH. LAST CLINIC VISIT HAD BEEN THREE DAYS PRIOR TO DEATH WITH NO SUSPICION OF DEVICE MALFUNCTION AND A HOLTER MONITOR NOTING RARE PREMATURE VENTRICULAR CONTRACTIONS. IT WAS UNKNOWN TO THE PHYSICIAN IF AUTOPSY WAS PERFORMED OR IF DEATH WAS RELATED TO DEVICE OR LEAD SYSTEM.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COLLAPSED AT A FOOTBALL GAME. "WAS IN PEA IN EMERGENCY ROOM." THE PATIENT IS REPORTED TO HAVE DIED (B)(6) 2010. NO DEVICE PROBLEMS HAD BEEN REPORTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THE PATIENT HAD BEEN PACEMAKER DEPENDENT.

    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 43 YR Death