MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L311

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inaccurate Synchronization (1609); Low impedance (2285)

Patient Problem Tachycardia (2095)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

This device has not been returned.However, investigation determined that the minute ventilation (mv) sensor in ingenio devices has the potential to increase the pacing rate to the maximum sensor rate more quickly than expected.As a result, a software update was released in 2013 that reduced the minimum mv response factor settings and re-distributed the remaining mv response factors to provide a consistent change in sensor rate across the range of mv response factors.This corrective action is expected to reduce, but not eliminate the occurrence of this behavior.

Event Description

It was reported that this patient presented in the emergency room due to experiencing tachycardia of 120bpm.The pacemaker was interrogated and it was noted that the device was pacing on maximum sensor rate when the patient was lying in a lateral position.Additionally, this pacemaker recorded two signal artifact monitoring (sam) episode.It was suspected that the patients tachycardia was induced by the minute ventilation (mv) sensor due to the physician turning off the mv feature and the tachycardia stopping and when the mv feature was turned back on, the tachycardia appeared a few seconds later.The patient was sent home with the device programming mv sensor disabled.Upon an office visit a few days later, the right atrial (ra) lead exhibited low out of range pacing impedance measurements, measuring less than 200 ohms.It was suspected that there was an issue with the ra lead insulation and noise was also noted on the atrial channel.Several tests were performed and the device was reprogrammed.Boston scientific technical services reviewed the available data and provided programming options and suggested lead replacement.No additional adverse patient effects were reported.This pacemaker and unknown ra lead remains in-service.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 14067954
• MDR Text Key: 289018141
• Report Number: 2124215-2022-07824
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2018
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 225254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other