BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II DR

    MDR report key: 1923537 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00927
    Event Type
    Death
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOLLOW UP LATER REVEALED CAUSE OF DEATH WAS ATHEROSCLEROTIC CARDIOVASCULAR DISEASE. NO AUTOPSY WAS PERFORMED. THE CLINIC REPORTED HIS LAST VISIT WITH THEM HAD BEEN ABOUT A MONTH PRIOR TO DEATH, HAVING SYMPTOMS OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. HE HAD RECEIVED AN APPROPRIATE SHOCK FOR VENTRICULAR TACHYCARDIA. DEVICE CHECK THAT DAY SHOWED IT WAS WORKING PROPERLY, THERE WERE NO CONCERNS REGARDING LEAD OR DEVICE PERFORMANCE, AND NO CHANGES WERE MADE TO THE DEVICE. FURTHER REPORTED THAT 17 DAYS PRIOR TO DEATH, PATIENT HAD AN ABNORMAL STRESS TEST AND WAS SCHEDULED FOR AN UPCOMING HEART CATHETERIZATION, BUT DIED BEFORE THAT COULD BE DONE.

    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. FOLLOW UP LATER REVEALED CAUSE OF DEATH WAS ATHEROSCLEROTIC CARDIOVASCULAR DISEASE. NO AUTOPSY WAS PERFORMED. THE CLINIC REPORTED HIS LAST VISIT WITH THEM HAD BEEN ABOUT A MONTH PRIOR TO DEATH, HAVING SYMPTOMS OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. HE HAD RECEIVED AN APPROPRIATE SHOCK FOR VENTRICULAR TACHYCARDIA. DEVICE CHECK THAT DAY SHOWED IT WAS WORKING PROPERLY, THERE WERE NO CONCERNS REGARDING LEAD OR DEVICE PERFORMANCE, AND NO CHANGES WERE MADE TO THE DEVICE. FURTHER REPORTED THAT 17 DAYS PRIOR TO DEATH, PATIENT HAD AN ABNORMAL STRESS TEST AND WAS SCHEDULED FOR AN UPCOMING HEART CATHETERIZATION, BUT DIED BEFORE THAT COULD BE DONE. EVALUATION SUMMARY - (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN FOUND DEAD ON (B)(6) 2010. INTERROGATION OF DEVICE IN MORGUE ON (B)(6) 2010 SHOWED THERE HAD BEEN ONE NON SUSTAINED TACHYCARDIA EPISODE AND ONE VF EPISODE ON (B)(6) 2010 THAT WERE DETECTED AND TREATED APPROPRIATELY. AN EGM PRIOR TO DETECTION AND ALSO POST SHOCK SHOWED THE VENTRICULAR CAPTURE WAS QUESTIONABLE AND THERE WAS NO EVIDENCE OF DEPOLARIZATION. LATER REPORTED THE SAVE TO DISC SHOWED THERE WAS NON CAPTURE IN THE VENTRICLE AND ATRIAL STANDSTILL. THE VF EPISODE HAD BEEN TREATED WITH ATP AND SHOCK, WHICH TERMINATED THE RHYTHM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN FOUND DEAD ON (B)(6) 2010. INTERROGATION OF DEVICE IN MORGUE ON (B)(6) 2010 SHOWED THERE HAD BEEN ONE NON SUSTAINED TACHYCARDIA EPISODE AND ONE VF EPISODE ON (B)(6) 2010 THAT WERE DETECTED AND TREATED APPROPRIATELY. AN EGM PRIOR TO DETECTION AND ALSO POST SHOCK SHOWED THE VENTRICULAR CAPTURE WAS QUESTIONABLE AND THERE WAS NO EVIDENCE OF DEPOLARIZATION. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN FOUND DEAD ON (B)(6) 2010. INTERROGATION OF DEVICE IN MORGUE ON (B)(6) 2010, SHOWED THERE HAD BEEN ONE NON SUSTAINED TACHYCARDIA EPISODE AND ONE VF EPISODE ON (B)(6) 2010 THAT WERE DETECTED AND TREATED APPROPRIATELY. AN EGM PRIOR TO DETECTION AND ALSO POST SHOCK SHOWED THE VENTRICULAR CAPTURE WAS QUESTIONABLE AND THERE WAS NO EVIDENCE OF DEPOLARIZATION. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. LATER REPORTED THE SAVE TO DISC SHOWED THERE WAS NON CAPTURE IN THE VENTRICLE AND ATRIAL STANDSTILL. THE VF EPISODE HAD BEEN TREATED WITH ATP AND SHOCK, WHICH TERMINATED THE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR ASKU LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death