MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO VIVA S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBB1D1

Device Problem Invalid Sensing (2293)

Patient Problem Loss of consciousness (2418)

Event Date 07/22/2014

Event Type  Injury  

Event Description

It was reported that the patient went into ventricular tachycardia but the device was "inappropriately programmed" to treat ventricular fibrillation only.Ambulance personnel found the patient unconscious.The rhythm degraded into ventricular fibrillation and was noted to be intermittently undersensed.The patient received a shock while receiving cardiopulmonary resuscitation.A lead integrity alert was also noted to be triggered for oversensing.The device was turned off while the patient was hospitalized.At a subsequent office visit, the device was reprogrammed.The lead remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: performance information was received and analyzed.Analysis of the device memory was performed and no anomalies were found.The device detected according to programmed settings.Concomitant products: 1258t, st.Jude lead, (b)(6) 2014; 1999-46, st.Jude lead, (b)(6) 2014; 305u221, tissue valve, (b)(6) 2013; 680r28, heart ring, (b)(6) 2008.(b)(4).

• Brand Name: VIVA S
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4161681
• MDR Text Key: 4771918
• Report Number: 3004209178-2014-19028
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2015
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2013
• 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
• Treatment: 693558 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00079 YR