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

Model Number L311

Device Problems Over-Sensing (1438); Use of Device Problem (1670)

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

Event Date 10/09/2020

Event Type  malfunction  

Event Description

It was reported that this pacemaker stored two signal artifact monitor (sam) episodes, with the most recent one causing the minute ventilation (mv) sensor to be disabled.A printout showed mv sensor noise on the right ventricular (rv) channel.The right atrial (ra) and rv leads were reprogrammed to the unipolar pacing and bipolar sensing configurations and the mv sensor remains off.The non-boston scientific leads showed normal measurements (sensing, impedance, thresholds were in range).No adverse patient effects were reported.The device remains implanted and in service.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker stored two signal artifact monitor (sam) episodes, with the most recent one causing the minute ventilation (mv) sensor to be disabled.A printout showed mv sensor noise on the right ventricular (rv) channel.The right atrial (ra) and rv leads were reprogrammed to the unipolar pacing and bipolar sensing configurations and the mv sensor remains off.The non-boston scientific leads showed normal measurements (sensing, impedance, thresholds were in range).No adverse patient effects were reported.The device remains implanted and in service.

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.

• 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: 14493730
• MDR Text Key: 292587960
• Report Number: 2124215-2022-14888
• Device Sequence Number: 1
• Product Code: LWP
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2021
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 453995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female