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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION INVIVE PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
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.
 
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Brand NameINVIVE
Type of DevicePULSE 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 Key8275894
MDR Text Key134034851
Report Number2124215-2019-00883
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
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 Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/07/2016
Device Model NumberV173
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2019 Patient Sequence Number: 1
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