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

Model Number L311

Device Problems High impedance (1291); Pacing Problem (1439)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 07/05/2022

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker experienced cardiac arrest.The patient was brought to the emergency room.Upon review, it was noted pacing inhibition.Troubleshooting efforts were performed, however, the patient is still unconscious.Subsequently, the patient was admitted to the intensive care unit.No additional adverse patient effects were reported.This product remains in service.

Manufacturer Narrative

Additional information was added to the following fields to capture the high out-of-range pacing impedances:.

Event Description

It was reported that the patient with this pacemaker experienced cardiac arrest.The patient was brought to the emergency room.Upon review, it was noted pacing inhibition.Additionally, it was noted that the pacemaker exhibited high out-of-range pacing impedance measurements on the non-boston scientific right ventricular (rv) lead, which triggered unipolar mode.Troubleshooting efforts were performed, however, the patient is still unconscious.Subsequently, the patient was admitted to the intensive care unit.No additional adverse patient effects were reported.This product remains in service.

• Brand Name: ACCOLADE MRI DR
• Type of Device: 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: 15111369
• MDR Text Key: 296658249
• Report Number: 2124215-2022-27628
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2023
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 579127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 90 YR
• Patient Sex: Male