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

Model Number L331

Device Problems Pacing Problem (1439); Inappropriate or Unexpected Reset (2959)

Patient Problems Undesired Nerve Stimulation (1980); Internal Organ Perforation (1987); Pneumothorax (2012); Sleep Dysfunction (2517); Syncope/Fainting (4411)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient with this pacemaker mentioned that during the implant procedure the lung was hit, leading to a complete deflation.The patient has not been able to sleep since hospital release.The pacemaker jolts and awakens the patient.Also, high heart rate beat has been observed with an extra beat.The device has been reprogrammed around the sleep apnea setting but did not work.Also, the programmed heart rate has been risen and the patient would like it reduced.Also, the patient reported experiencing blacking outs.According to the field representative, they were not involved during this process, but they know that the pacemaker remains in service and the patient is doing well.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE MRI EL 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: 16596715
• MDR Text Key: 311818686
• Report Number: 2124215-2023-13691
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 568304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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 Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male