MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA1Q1

Device Problem False Alarm (1013)

Patient Problem Syncope (1610)

Event Date 05/23/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 459888 lead, implanted (b)(6) 2015, product event summary: the actual product was not returned for analysis.However, performance data was collected from the device and was analyzed.Analysis of the device memory indicated a false alert for the right ventricular lead integrity alert.A ventricular fibrillation (vf) episode on (b)(6) 2016 caused lead integrity alert (lia) to trigger inappropriately.The fine vf caused 163 short interval counts (sic).

Event Description

It was reported that the patient became unconscious in the intensive care unit because they experienced a ventricular tachycardia (vt) episode that was outside the detection/treatment zone and ventricular fibrillation (vf) that took a long time to detect due to higher than typical vt and vf therapy zone rate settings.The vt/vf caused a false lead integrity alert (lia) to trigger.The number of intervals to detect were increased which compounded the problem on later episodes.The implantable cardioverter defibrillator (icd) was working as it was programmed.The icd was turned off and remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: VIVA QUAD XT
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5860634
• MDR Text Key: 51695587
• Report Number: 3004209178-2016-16078
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

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: Lay User/Patient
• Device Expiration Date: 03/28/2016
• Device Model Number: DTBA1Q1
• Device Catalogue Number: DTBA1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: 05/24/2016
• Supplement Dates FDA Received: 09/23/2017
• Date Device Manufactured: 09/29/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 64 YR