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); Use of Device Problem (1670)

Patient Problem Asystole (4442)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that this patient presented to their health care professional (hcp) for routine follow up post transcatheter aortic valve (tavr) replacement surgery.The hcp noted that during the tavr procedure, there was a three second pause observed on the electrocardiogram (ekg) as a result of oversensing noise.The noise was suspected to be a result of electrocautery use during the procedure.Additionally, it was noted that a magnet was not used during the procedure.Technical services (ts) was consulted and provided pacemaker surgical education guidance for future procedure where electrocautery use will be required.During the in-office visit, isometrics were performed and unable to reproduce noise.All diagnostic measurements were stable and the device didn't store any related episodes.Ts recommended to continue regular monitoring and device follow up.At this time, the device 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: 15074179
• MDR Text Key: 296348994
• Report Number: 2124215-2022-26737
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2024
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 980032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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: 79 YR
• Patient Sex: Male