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); Failure to Read Input Signal (1581); Low impedance (2285)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It was reported that this pacemaker and right atrial (ra) lead exhibited an out-of-range pacing impedance measurement less than 200 ohms resulting in a signal artifact monitor (sam) episode, and deactivation of the minute ventilation (mv) feature.Additionally, out-of-range intrinsic amplitude measurements were observed and stored atrial tachy response (atr) episodes were reviewed that contained oversensing of noise.Technical services (ts) recommended further review by the physician.No further assistance was requested at this time.No adverse patient effects were reported.This device remains in service.If information is provided in the future, a supplemental report will be issued.

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)/respiratory 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 this pacemaker and right atrial (ra) lead exhibited an out-of-range pacing impedance measurement less than 200 ohms resulting in a signal artifact monitor (sam) episode, and deactivation of the minute ventilation (mv) feature.Additionally, out-of-range intrinsic amplitude measurements were observed and stored atrial tachy response (atr) episodes were reviewed that contained oversensing of noise.Technical services (ts) recommended further review by the physician.No further assistance was requested at this time.No adverse patient effects were reported.This device remains in service.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: 15892681
• MDR Text Key: 307800416
• Report Number: 2124215-2022-50140
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2023
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 925529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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: 76 YR