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

Model Number L331

Device Problems Pacing Problem (1439); Migration (4003)

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

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device appeared to exhibit instances where the minute ventilation (mv) sensor did not respond as expected at higher rates.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the minute ventilation (mv) sensor in this pacemaker did not work as expected when the patient was performing the rowing movement, nonetheless, in other activities is working as expected.The health care professional (hcp) wonder if the pacemaker could be moving in the pocket.Technical services (ts) suggested having the patient hold off on rowing type motion for several weeks and give pocket time to adjust to the pacemaker.This pacemaker remains in service.No adverse patient effects were reported.

Event Description

It was reported that the minute ventilation (mv) sensor in this pacemaker did not work as expected when the patient was performing the rowing movement, nonetheless, in other activities is working as expected.The health care professional (hcp) wonder if the pacemaker could be moving in the pocket.Technical services (ts) suggested having the patient hold off on rowing type motion for several weeks and give pocket time to adjust to the pacemaker.Additional information was received which indicated that the patient was in clinic for a follow up.It was noted that during biking the mv feature performed as expected, nonetheless, during activities of daily living (adl) when involving shoulder exercises, the sensor overreacts.Ts recommended changing the ventilatory threshold.This pacemaker remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device appeared to exhibit instances where the minute ventilation (mv) sensor did not respond as expected at higher rates.Please refer to the description for more information regarding the specific circumstances of this event.

• 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: 15611045
• MDR Text Key: 306066306
• Report Number: 2124215-2022-41566
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 534949
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: 67 YR
• Patient Sex: Male