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

Model Number L311

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)

Patient Problem Syncope/Fainting (4411)

Event Date 01/25/2023

Event Type  Injury  

Event Description

It was reported that this pacemaker had entered safety mode, and codes 0xa 0xa 0xa were identified upon interrogation.It was noted that the patient had a syncopal episode due to unipolar oversensing and pacing inhibition while the device was in safety mode.Subsequently, the pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker will be returned for analysis.

Manufacturer Narrative

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

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.-- correction b3: upon further review, it was determined that the event date was (b)(6) 2023, not (b)(6) 2023.The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this pacemaker had entered safety mode, and codes 0xa 0xa 0xa were identified upon interrogation.It was noted that the patient had a syncopal episode due to unipolar oversensing and pacing inhibition while the device was in safety mode.Subsequently, the pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker will be returned for analysis.Additional information received reported that consult interrogation with this pacemaker was attempted and unsuccessful, however this was prior to identifying that this pacemaker had entered safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

Event Description

It was reported that this pacemaker had entered safety mode, and codes 0xa 0xa 0xa were identified upon interrogation.It was noted that the patient had a syncopal episode due to unipolar oversensing and pacing inhibition while the device was in safety mode.Subsequently, the pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker will be returned for analysis.Additional information received reported that consult interrogation with this pacemaker was attempted and unsuccessful, however this was prior to identifying that this pacemaker had entered safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.-- correction b3: upon further review, it was determined that the event date was (b)(6) 2023, not (b)(6) 2023.The product has been received for analysis.This report will be updated upon completion of analysis.-- upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode.It was verified that critical therapy remained available.Memory review also determined the device had recorded four errors which is why it appropriately moved to safety mode operation.During testing, the device operated as expected.The root cause of the errors recorded by the device could not be confirmed.

Event Description

It was reported that this pacemaker had entered safety mode, and codes 0xa 0xa 0xa were identified upon interrogation.It was noted that the patient had a syncopal episode due to unipolar oversensing and pacing inhibition while the device was in safety mode.Subsequently, the pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker will be returned for analysis.Additional information received reported that consult interrogation with this pacemaker was attempted and unsuccessful, however this was prior to identifying that this pacemaker had entered safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.-- correction b3: upon further review, it was determined that the event date was (b)(6)2023, not (b)(6)2023.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.Dimensional analysis of the header was completed.Each port measured as expected.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.

• 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: 16292701
• MDR Text Key: 308734582
• Report Number: 2124215-2023-04339
• 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,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2023

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: Lay User/Patient
• Device Expiration Date: 04/14/2018
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 228273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 01/26/2023; 07/13/2023; 08/11/2023
• Supplement Dates FDA Received: 02/10/2023; 08/05/2023; 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male