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

Model Number L311

Device Problems Pacing Problem (1439); Data Problem (3196)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint device was not returned to bsc so product analysis could not be performed.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.

Event Description

It was reported that this patient with this pacemaker presented to their health care facility for routine follow up and device optimization.The patient is an active hiker and has device feature, minute ventilation (mv) rate response enabled.Upon further review, it was found when the patient is sitting down and not moving, the patient's maximum sensor rate increases to 145 beats per minute.Technical services (ts) was consulted and discussed programming and troubleshooting recommendations.The plan is to perform additional troubleshooting.At this time, the device remains in service.No adverse patient effects were reported.

• 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: 15712332
• MDR Text Key: 306638194
• Report Number: 2124215-2022-44866
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/04/2021
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 413099
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female