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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P IMPLANTABLE DEVICE Back to Search Results
Model Number U225
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Nausea (1970); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330)
Event Date 06/04/2021
Event Type  Injury  
Event Description
It was reported that this patient with an implanted cardiac resynchronization therapy pacemaker (crt-p) system was experiencing chronic pain on their left side and diaphragmatic stimulation. Boston scientific technical services (ts) reviewed all left ventricular (lv) lead programming options with the healthcare provider (hcp) and each option was tested. The lv lead is not a boston scientific product. The patient felt some symptoms with each lv programming option that was tested, including in some cases experiencing pain, discomfort with pacing, nausea, chest pressure and undesired sensations. Ts asked the hcp to test right ventricular (rv) lead-only pacing to attempt to rule out the lv lead. The hcp indicated that the patient feels best with rv lead-only pacing and asked if they should make this a permanent programming change. Ts discussed that this is a clinical decision and the hcp indicated they will discuss this with the physician. The products remain in-service. No additional adverse patient effects were reported.
 
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Brand NameVISIONIST CRT-P
Type of DeviceIMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key12185167
MDR Text Key262151744
Report Number2124215-2021-19805
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030005/S138
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberU225
Device Catalogue NumberU225
Device Lot Number715450
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 Received06/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2020
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: 07/16/2021 Patient Sequence Number: 1
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