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

Model Number L331

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that electrogram (egm) review was requested for this pacemaker due to several stored atrial tachy response (atr) episodes that appeared to contain noise.Review of atrial tachycardia / atrial fibrillation (at/af) burden showed chronically high atrial rates for greater than a month, however review of the atr episodes showed possible atrial flutter along with the noise.Additionally, review of data near implant shows unusual right atrial (ra) signals that may have been attributed to ra lead placement.Clinic notes indicate ra sensitivity was previously adjusted to address farfield signal oversensing, which suggests that there was now some atrial undersensing.Technical services (ts) recommended bringing the patient in-clinic for programming optimization.This pacemaker system remains in service.No adverse patient effects were reported.

• 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: 18764650
• MDR Text Key: 336214855
• Report Number: 2124215-2024-10754
• Device Sequence Number: 1
• Product Code: LWP
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2019
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 752320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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: 72 YR
• Patient Sex: Female