MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE DR; IMPLANTABLE PACEMAKER

Model Number L301

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Data Problem (3196)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that this pacemaker recorded a false signal artifact monitoring event for what looked like electromagnetic interference.The impedance values on the right ventricular lead were within normal limits but on the right atrial lead could not be measured due to the present noise.The patient rhythm was right atrial pace, then right ventricular pace due to noise response throughout.The 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.

• Brand Name: ACCOLADE DR
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 18500640
• MDR Text Key: 333209324
• Report Number: 2124215-2024-01456
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2018
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 732317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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: 75 YR
• Patient Sex: Female