MAUDE Adverse Event Report: IPG MFG SWITZERLAND VIVA QUAD XT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTBA2QQ

Device Problems Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Loss of consciousness (2418)

Event Date 10/23/2014

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.Analysis of the device memory indicated oversensing due to non-physiologic signals/sic (sensing integrity counter).No anomalies found with sensing.Sensing integrity counts went up to 57 since (b)(6) 2014 these sics were detected as at/af episodes.Evidence of oversensing during (b)(6) 2014.The device was subsequently returned and analyzed.No anomalies were found.

Manufacturer Narrative

Product event summary: performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to non-physiologic signals/sic (sensing integrity counter).Sensing integrity counts went up to 57 since (b)(4) 2014 these sics were detected as at/af episodes.Evidence of oversensing during (b)(4) 2014.The analyst commented that since there is an allegation against sensitivity issues, a sigma pace test for sensitivity should have been performed.Device was functional tested and it is not possible to perform this test.However, sensitivity passed on the functional test.The device was subsequently returned and analyzed.No anomalies were found.

Event Description

It was reported that the right ventricular lead (rv) had loss of capture thought to be from oversensing/noise during a surgical procedure.The sensitivity was adjusted and the lead and device remained in use.Shortly after this incident the patient experienced collapse and loss of consciousness.The r-wave was noted to be decreasing and no output on the implantable cardioverter defibrillator (icd).A sensing problem with the device was suspected as well as a micro dislodgement of the rv lead.The device and lead were explanted and replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the united states, however, it is similar to a device marketed in the u.S.The event is being reported due to an alleged malfunction.This event occurred outside the us where a similar model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

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): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 4314408
• MDR Text Key: 13194975
• Report Number: 9614453-2014-03069
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2014

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: 10/14/2014
• Device Model Number: DTBA2QQ
• Device Catalogue Number: DTBA2QQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/13/2015
• Supplement Dates FDA Received: 04/10/2015; 06/10/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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: 6947M62 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention