BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE EPI

    MDR report key: 1200144 · Received October 16, 2008

    Report

    Report Number
    2182208-2008-00305
    Event Type
    Death
    Date Received
    October 16, 2008
    Date of Event
    September 18, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED. EVALUATION SUMMARY: NO ANOMALIES FOUND; FULL LEAD RETURNED AND ANALYZED. NO ANOMALIES FOUND IT WAS REPORTED THE PATIENT HAD BEEN SEPTIC "CAUSING ORGANS/SYSTEMS TO SHUT DOWN." THERE WAS NO CONCERN FROM THE MEDICAL STAFF THAT THE SEPSIS WAS DEVICE RELATED. THE PATIENT CODED AND THE PHYSICIAN OBSERVED PACING SPIKES DURING THIS TIME. THE PATIENT DIED AND AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION PROVIDED BY THE FORENSIC PATHOLOGIST STATED THE CAUSE OF DEATH WAS SUDDEN DEATH ASSOCIATED WITH CONGENITAL AV BLOCK. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION DEVICE PERFORMED, ACCORDING TO SPECIFICATIONS NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN SEPTIC "CAUSING ORGANS/SYSTEMS TO SHUT DOWN." THERE WAS NO CONCERN FROM THE MEDICAL STAFF THAT THE SEPSIS WAS DEVICE RELATED. THE PATIENT CODED AND THE PHYSICIAN OBSERVED PACING SPIKES DURING THIS TIME. THE PATIENT DIED AND AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION PROVIDED BY THE FORENSIC PATHOLOGIST STATED THE CAUSE OF DEATH WAS SUDDEN DEATH ASSOCIATED WITH CONGENITAL AV BLOCK. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Death| O| R