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

Model Number L331

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv) sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the minute ventilation sensor signal oversensing advisory population.

Event Description

It was reported that during a review of battery data for this pacemaker, two signal artifact monitor (sam) episodes were found, stored in (b)(6) 2020.In the episodes, minute ventilation (mv) sensor noise/artifact was observed on the non-boston scientific right atrial (ra) and right ventricular (rv) leads, which caused the mv sensor to disable.A review of the lead trends confirmed stable pacing impedance values over the past year.Currently, the mv sensor remains disabled, resolving the mv sensor noise issue.Additionally, there were two episodes stored showing noise oversensing on the ra and rv channels consistent with electromagnetic interference (emi), one in (b)(6) 2020 and another more recently in (b)(6) 2021.No adverse patient effects were reported.The device and leads remain implanted and in service.

• Brand Name: ACCOLADE MRI EL 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: 12515742
• MDR Text Key: 272860729
• Report Number: 2124215-2021-24671
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2017
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 700298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR