BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1706806 · Received June 2, 2010

    Report

    Report Number
    2649622-2010-05122
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    March 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. (B) (4) DEFIB CONDUCTOR FRACTURED. FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. (B) (4) DEFIB CONDUCTOR FRACTURED. FULL LEAD RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) NO ANOMALIES FOUND. (B) (4) DEFIB CONDUCTOR FRACTURED. FULL LEAD RETURNED AND ANALYZED. CLINIC LATER REPORTED LAST REMOTE CHECK (B) (6) 2010 WAS FINE. ALSO REPORTED PATIENT PALE AND DIAPHORETIC IN AMBULANCE, HAD PEA (PULSELESS ELECTRICAL ACTIVITY) IN AMBULANCE, AND WAS STILL IN PEA UPON ARRIVAL TO THE EMERGENCY ROOM. FOLLOW UP REPORTED THE PATIENT WAS NOT PACEMAKER DEPENDENT AND HAD LAST BEEN SEEN BY THE PHYSICIAN (B) (6) 2009 - DEVICE WAS FINE. THE HOSPITAL RECORD REPORTS DEATH WAS SECONDARY TO CARDIAC ARREST AND PATIENT HAD "IMPLANTED PACEMAKER, WHICH WAS NOT FIRING TO OUR VISIBILITY DURING THE CODE."

    Description of Event or Problem · 1

    PATHOLOGIST REPORTED PATIENT HAD A "COMPLICATED DEATH" AND THERE WAS POSSIBLE MALFUNCTION OR DEFECT OF THE DEVICE RELATED TO THE PATIENT'S DEATH. LEAD RETURNED TO MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH PHYSICIAN REPORTED CAUSE OF DEATH TO BE IDIOPATHIC HYPERTROPHIC CARDIOMYOPATHY. PATIENT HAD HISTORY OF HYPERTENSION. WAS ON TOILET (B) (6) 2010 WHEN HE BECAME UNRESPONSIVE AND ARRIVED AT HOSPITAL IN BRADYCARDIC RHYTHM WITH BIGEMINY. THEY HAD DIFFICULTY INTERROGATING DEVICE AND "IT WASN'T ACTING LIKE IT SHOULD." PATIENT CODED, WAS UNABLE TO BE RESUSCITATED, AND DIED IN EMERGENCY ROOM. THE PATIENT HAD LAST BEEN SEEN IN THE CLINIC (B) (6) 2009 FOR SHORTNESS OF BREATH WITH "THICKENING OF SPUTUM" AND DEVICE AND LEAD NOTED TO BE FINE. CLINIC LATER REPORTED LAST REMOTE CHECK (B) (6) 2010 WAS FINE. ALSO REPORTED PATIENT PALE AND DIAPHORETIC IN AMBULANCE, HAD PEA (PULSELESS ELECTRICAL ACTIVITY) IN AMBULANCE, AND WAS STILL IN PEA UPON ARRIVAL TO THE EMERGENCY ROOM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATHOLOGIST THAT THE PATIENT HAD A "COMPLICATED DEATH" AND THERE WAS A POSSIBLE MALFUNCTION OR DEFECT OF THE DEVICE RELATED TO THE PATIENT'S DEATH. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH THE PHYSICIAN REPORTED CAUSE OF DEATH TO BE IDIOPATHIC HYPERTROPHIC CARDIOMYOPATHY. PATIENT HAD HISTORY OF HYPERTENSION. PATIENT WAS ON THE TOILET (B) (6) 2010 WHEN HE BECAME UNRESPONSIVE AND ARRIVED AT HOSPITAL IN A BRADYCARDIC RHYTHM WITH BIGEMINY. THEY HAD DIFFICULTY INTERROGATING DEVICE AND "IT WASN'T ACTING LIKE IT SHOULD." PATIENT CODED, WAS UNABLE TO BE RESUSCITATED, AND DIED IN EMERGENCY ROOM. THE PATIENT HAD LAST BEEN SEEN IN THE CLINIC (B) (6) 2009 FOR SHORTNESS OF BREATH WITH "THICKENING OF SPUTUM."

    Description of Event or Problem · 1

    PATHOLOGIST REPORTED PATIENT HAD A "COMPLICATED DEATH" AND THERE WAS POSSIBLE MALFUNCTION OR DEFECT OF THE DEVICE RELATED TO THE PATIENT'S DEATH. LEAD RETURNED TO MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. FOLLOW UP WITH PHYSICIAN REPORTED CAUSE OF DEATH TO BE IDIOPATHIC HYPERTROPHIC CARDIOMYOPATHY. PATIENT HAD HISTORY OF HYPERTENSION. WAS ON TOILET (B) (6) 2010 WHEN HE BECAME UNRESPONSIVE AND ARRIVED AT HOSPITAL IN BRADYCARDIC RHYTHM WITH BIGEMINY. THEY HAD DIFFICULTY INTERROGATING DEVICE AND "IT WASN'T ACTING LIKE IT SHOULD." PATIENT CODED, WAS UNABLE TO BE RESUSCITATED, AND DIED IN EMERGENCY ROOM. THE PATIENT HAD LAST BEEN SEEN IN THE CLINIC (B) (6) 2009 FOR SHORTNESS OF BREATH WITH "THICKENING OF SEPTUM" AND DEVICE AND LEAD NOTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death 5076 IMPLANTABLE PACING LEAD