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

Model Number L331

Device Problems Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)

Patient Problem Chest Pain (1776)

Event Date 02/06/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this patient with this pacemaker was seeking recommendation for optimal rate response settings for this device.This patient is a very active person with their primary activity being long swimming.Technical services (ts) recommended a discussion with this patients physician for programming optimization.This patients pacemaker was reprogrammed approximately 2 months later as it was claimed that this patients heart rate (hr) was not rising high enough.Months later, this patient was still experiencing issues with their hr dropping while swimming.Ts recommended disk analysis to review the sensor data.It was noted that this patient experienced chest tension when their hr was too low or too high.Ts discussed this patient obtaining an interrogation with the local field representative and clinic.It was noted that this patient was really frustrated with the lack of ability to swim as they used to.Disk analysis has been requested and is still pending.This pacemaker remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this patient with this pacemaker was seeking recommendation for optimal rate response settings for this device.This patient is a very active person with their primary activity being long swimming.Technical services (ts) recommended a discussion with this patients physician for programming optimization.This patients pacemaker was reprogrammed approximately 2 months later as it was claimed that this patients heart rate (hr) was not rising high enough.Months later, this patient was still experiencing issues with their hr dropping while swimming.Ts recommended disk analysis to review the sensor data.It was noted that this patient experienced chest tension when their hr was too low or too high.Ts discussed this patient obtaining an interrogation with the local field representative and clinic.It was noted that this patient was really frustrated with the lack of ability to swim as they used to.Disk analysis has been requested and is still pending.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received that this patient underwent additional exercises in which ts observed what was believed to be some rare over and undersensing.Disk analysis was sent in and will be analyzed.This pacemaker remains in service.No adverse patient effects were reported.

Event Description

It was reported that this patient with this pacemaker was seeking recommendation for optimal rate response settings for this device.This patient is a very active person with their primary activity being long swimming.Technical services (ts) recommended a discussion with this patients physician for programming optimization.This patients pacemaker was reprogrammed approximately 2 months later as it was claimed that this patients heart rate (hr) was not rising high enough.Months later, this patient was still experiencing issues with their hr dropping while swimming.Ts recommended disk analysis to review the sensor data.It was noted that this patient experienced chest tension when their hr was too low or too high.Ts discussed this patient obtaining an interrogation with the local field representative and clinic.It was noted that this patient was really frustrated with the lack of ability to swim as they used to.Disk analysis has been requested and is still pending.This pacemaker remains in service.No adverse patient effects were reported.Additional information was received that this patient underwent additional exercises in which ts observed what was believed to be some rare over and undersensing.Disk analysis was sent in and will be analyzed.This pacemaker remains in service.No adverse patient effects were reported.Analysis revealed that the minute ventilation (mv) sensor is picking up impedance changes due to this device and lead movement when this patient moves his left arm in a swimming motion.The frequency of the mv signal matches the arm motion frequency, not the frequency of respirations.This patient is a swimmer and this is the source of the inappropriate mv response.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 15772776
• MDR Text Key: 307284483
• Report Number: 2124215-2022-46560
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/23/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 915879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: 73 YR
• Patient Sex: Male