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

Model Number L311

Device Problems Failure to Capture (1081); Pacing Problem (1439)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418); Convulsion/Seizure (4406); Syncope/Fainting (4411); Asystole (4442)

Event Date 09/17/2022

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the patient was hospitalized after experiencing syncope with loss of consciousness and a seizure due to loss of capture and pacing inhibition with asystole.While in the emergency room (er), threshold testing was performed on both chambers.At the end of testing the right ventricular (rv) lead, loss of capture was observed and pacing did not resume for multiple seconds.Stat pacing was administered through the programmer and the device resumed pacing.Upon explanting and replacing the pacemaker, threshold testing was performed on the new pacemaker at 90 bpm and revealed normal function and good measurements.Further threshold testing was performed on the original rv lead at 120 bpm, and high thresholds were observed.The rv lead was explanted and replaced.Upon removal of the last suture on the rv lead, the lead sprung back; this suggested that lead dislodgement had occurred.No additional adverse patient effects were reported.The explanted pacemaker and rv lead have been received for analysis.

Event Description

It was reported that the patient was hospitalized after experiencing syncope with loss of consciousness and a seizure due to loss of capture and pacing inhibition with asystole.While in the emergency room (er), threshold testing was performed on both chambers.At the end of testing the right ventricular (rv) lead, loss of capture was observed and pacing did not resume for multiple seconds.Stat pacing was administered through the programmer and the device resumed pacing.Upon explanting and replacing the pacemaker, threshold testing was performed on the new pacemaker at 90 bpm and revealed normal function and good measurements.Further threshold testing was performed on the original rv lead at 120 bpm, and high thresholds were observed.The rv lead was explanted and replaced.Upon removal of the last suture on the rv lead, the lead sprung back; this suggested that lead dislodgement had occurred.No additional adverse patient effects were reported.The explanted pacemaker and rv lead have been received for analysis.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.-- the returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ACCOLADE MRI 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: 15547997
• MDR Text Key: 301234785
• Report Number: 2124215-2022-39997
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• 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: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 635083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 90 KG