MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Under-Sensing (1661); Unintended Electrical Shock (4018)

Patient Problem Death (1802)

Event Date 12/25/2018

Event Type  Death  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

It was "report" that this health care professional contacted boston scientific technical services.The consultant was informed that this patient had died on (b)(6) 2018.A review of the episode found that the ventricular tachycardia appears just prior to an automatic capture test.A successful right ventricular automatic threshold (rvat-1704) occurred on (b)(6) 2018 at 0356.The next scheduled test should have occurred at 0056 on (b)(6) 2018.The completion of the episode could not be viewed.The device rate smoothing feature is programmed on.In the long vt episode at 0056 on (b)(6) 2018, a capture output voltage indicates that the test had already started.The rhythm terminated following a short run of vt.This was followed by three 1.0 volt threshold markers and a few beats of vt.Two 0.9 volt threshold markers occurred with rate smoothing.There is one beat of functional undersensing ap-biv pacing which is then followed by vt.The consultant could not rule out that the device may have caused or contribute to the vt as the last event could have been an r-on-t.The vt cycle length is very fast (250-300 ms) associated with va dissociation and appeared to be right-sided.The intermittent rvat attempts are due to rhythm termination.Rate smoothing forced faster pacing with some evidence of tachycardia undersensing.Lead diagnostics appeared acceptable and were within normal limits.The vt from episode# v-16 lasted for 10 minute 32 seconds.There were four more episodes on (b)(6) 2018 at 0107, 0108, 0109 and 0111.No electrograms were available for review for episode# v-17 at 0107.The other three episodes had electrograms.The average heart rates for all five episodes were 232, 205, 183, 182 and 152 bpm.The consultant briefly reviewed the more recent episodes which showed evidence of undersensing, functional undersensing (due to trigger pacing and rate smoothing) and normal sensed vt.Further analysis found that the most recent daily recorded measurement was on (b)(6) 2018 at 0356 for 0.8 volts.The most recent recorded measurement was taken on (b)(6) 2018 at 0251 and was an evoked response for less than a minute.Based on review of the printout from episode#16, product involvement could not be ruled out.

• Brand Name: INVIVE
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8275894
• MDR Text Key: 134034851
• Report Number: 2124215-2019-00883
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2016
• Device Model Number: V173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 79 YR