MAUDE Adverse Event Report: MEDTRONIC, INC. VIVA XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1D4

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Death (1802); Tachycardia (2095); Vomiting (2144); Multiple Organ Failure (3261)

Event Date 06/05/2015

Event Type  Death  

Manufacturer Narrative

Mw5075651.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient¿s spouse the patient is deceased.It was also reported the patient¿s heart was out of rhythm for approximately five to seven days, there was not a shock and the spouse felt the patient should have been shocked during this time.Prior to death the patient complained of being tired and on one occasion ate a sandwich and vomited all night long what appeared to be a brown colored substance that ¿looked like gravy.¿ the physician was called, the patient was seen in office, admitted to the hospital, and transferred to the intensive care unit (icu).The patient was placed on a ventilator for several days.When the spouse asked the physician what happened, the response was ¿the heart was out of rhythm and it was like the patient had been running a marathon for five to seven days, at twenty-four hours a day, and the organs have shut down.¿ an attempt to get the heart back into rhythm was unsuccessful.Following, a surgical ablation was performed, which helped; however, ¿the organs were still messed up.¿ the patient was moved to a room, discharged, spent three days in rehabilitation, and was then re-admitted with multiple blood clots in the lung.Placement of a vena cava filter was performed, the patient was sent to the icu, then to rehabilitation, and back to the icu.The spouse was advised the patient would not live.The spouse took the patient home and was told ¿would not make it through the weekend.¿ a nurse asked if they wanted to disconnect the implantable cardioverter defibrillator (icd) and the family declined.After the patient was home the patient ¿jumped, was very distraught, and hollered.The machine shocked that night and hurt the patient.Two days later, the spouse had it turned off.¿.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7371931
• MDR Text Key: 103512254
• Report Number: 2182208-2018-00341
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DTBA1D4
• Device Catalogue Number: DTBA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention