BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM DR

    MDR report key: 1920131 · Received December 10, 2010

    Report

    Report Number
    2647346-2010-00816
    Event Type
    Death
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    ASKU

    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, PROXIMAL CONDUCTOR DISTORTED AND BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ESC AND BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR STRETCHED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ESC AND BREACHED CUT AND COSMETIC DEPRESSION, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND.

    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, PROXIMAL CONDUCTOR DISTORTED AND BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ESC AND BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, DISTAL CONDUCTOR STRETCHED, PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC ESC AND BREACHED CUT AND COSMETIC DEPRESSION, HELIX/LOBE DISTORTED/BENT, BLOOD IN/ON HELIX/LOBE MECHANISM, APPARENT EXPLANT DAMAGE. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT SCUBA DIVING IN 18 FEET OF WATER. SHORTLY AFTER COMING OUT OF WATER, TALKING WITH COMPANIONS, REPORTED FEELING ILL AND PATIENT SUDDENLY COLLAPSES WITH SEIZURE LIKE ACTIVITY. BYSTANDER CPR INITIATED AND TRANSPORTED TO THE EMERGENCY ROOM WHERE DIED. FOLLOW UP WITH MEDICAL EXAMINER REVEALED CAUSE OF DEATH WAS ACUTE CARDIAC DYSRHYTHMIA WHILE SCUBA DIVING DUE TO ISCHEMIC HEART DISEASE WITH NO ALLEGATION OF ANY DEVICE PERFORMANCE ISSUES RELATED TO THE DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN SCUBA DIVING IN 18 FEET OF WATER. SHORTLY AFTER COMING OUT OF THE WATER, WAS TALKING WITH COMPANIONS AND PATIENT SUDDENLY COLLAPSES. THE PATIENT DIED (B)(6) 2010. ADDITIONAL INFORMATION AND THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death