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

Model Number L311

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this pacemaker had entered safety mode and the patient experienced pacing inhibition and oversensing of unipolar pacing.Upon interrogation, the pacemaker revealed codes 0xc 0xc 0xc.This pacemaker was later explanted and replaced due to noise, oversensing, and safety mode.No additional adverse patient effects were reported.This pacemaker is expected for device return.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.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 and that brady therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

Event Description

It was reported that this pacemaker had entered safety mode and the patient experienced pacing inhibition and oversensing of unipolar pacing.Upon interrogation, the pacemaker revealed codes 0xc 0xc 0xc.This pacemaker was later explanted and replaced due to noise, oversensing, and safety mode.No additional adverse patient effects were reported.This pacemaker is expected for device return.

• 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: 15984964
• MDR Text Key: 305490992
• Report Number: 2124215-2022-52834
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2020
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 340106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male