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

Model Number EVERA XT

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Ventricular Tachycardia (2132); Respiratory Failure (2484)

Event Date 02/27/2017

Event Type  Death  

Event Description

An elderly patient who was admitted to the hospital on late (b)(6) for multiple inappropriate firing of her defibrillator (11 firings in the last hour at 1:53pm).After transfer to the floor the patient was seen by the (b)(4) rep who interrogated the defibrillator.In the (b)(4) rep's written note it was determined that the patient was receiving inappropriate firing from her defibrillator.Rep discussed with cardiac dr.Over the phone and it was decided to turn off the defibrillator but continue the pacemaker function.It was reported that the patient get into a polymorphic ventricular tachycardia at 0120 which code blue was called.Patient received 1 shock and regained a rhythm.Patient was subsequently transferred to cardiovascular intensive care unit (cvicu) and was reported awake and talking.Around 0205, the patient went into respiratory arrest and on telemetry it appears she went into ventricular tachycardia.Code blue procedures were initiated which were unsuccessful.The patient was pronounced dead at 0235.Manufacturer response for implantable cardioverter-defibrillator, (b)(4) (per site reporter): investigated the icd and found that it has a fault.

• Brand Name: EVERA XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATI
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 6398602
• MDR Text Key: 69758605
• Report Number: 6398602
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017,03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EVERA XT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 50