MAUDE Adverse Event Report: MEDTRONIC INC. EVERA XT VR; GENERATOR

Model Number DVBBID4

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Unknown (for use when the device problem is not known) (2204)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Renal Failure (2041)

Event Date 05/14/2014

Event Type  Death  

Event Description

Death.Patient had a cardiac arrest in the icu unit.After cpr had been done for 30 minutes, and an echo showed no wall motion, it was felt that the defibrillator should be turned off.Therefore, the cardiologist programmed the defibrillator off and the pacemaker to ovo.The patient went back into ventricular fibrillation.The patient did code again and then expired.

• Brand Name: EVERA XT VR
• Type of Device: GENERATOR
• Manufacturer (Section D): MEDTRONIC INC.; 7000 central ave. n.e.; minneapolis MN 55432 308
• MDR Report Key: 4170505
• MDR Text Key: 19722772
• Report Number: 4170505
• Device Sequence Number: 1
• Product Code: DTE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DVBBID4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2014
• Distributor Facility Aware Date: 09/22/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 115