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

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.

• Brand Name: VISIONIST CRT-P
• Type of Device: IMPLANTABLE 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 Key: 12185167
• Report Number: 2124215-2021-19805
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• 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 Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/05/2022
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 715450
• 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 Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial
• Patient Age: 80 YR
• Patient Outcome(s): Other