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); Use of Device Problem (1670)

Patient Problem Malaise (2359)

Event Date 07/29/2022

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.The patient presented to the clinic because he was not feeling well, and it was noted that he had congenital heart block (chb).The field representative believed the patient was feeling unwell due to the loss of rate response once the pacemaker entered safety mode.It was also likely the patient felt unwell due to oversensing and pacing inhibition of unipolar pacing.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that this pacemaker had entered safety mode.The patient presented to the clinic because he was not feeling well, and it was noted that he had congenital heart block (chb).The field representative believed the patient was feeling unwell due to the loss of rate response once the pacemaker entered safety mode.It was also likely the patient felt unwell due to oversensing and pacing inhibition of unipolar pacing.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

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 bradycardia therapy remained available.The device was in safety mode when received and could not connect telemetry to test these allegations.With an external power supply the device functioned normally.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.However, probable cause could not be determined because the device is functioning normally and the battery has no failures.

Manufacturer Narrative

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 confirmed that critical therapy remained available.Review of device memory identified evidence that random access memory (ram) had been compromised, which can be indicative of power being lost and then restored.The device case was opened and the battery was removed and forwarded for detailed testing.Despite analysis, the root cause of the clinical observations could not be confirmed.

Event Description

It was reported that this pacemaker had entered safety mode.The patient presented to the clinic because he was not feeling well, and it was noted that he had congenital heart block (chb).The field representative believed the patient was feeling unwell due to the loss of rate response once the pacemaker entered safety mode.It was also likely the patient felt unwell due to oversensing and pacing inhibition of unipolar pacing.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Device telemetry data confirmed it was operating in safety mode, it had undergone resets, and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.

Event Description

It was reported that this pacemaker had entered safety mode.The patient presented to the clinic because he was not feeling well, and it was noted that he had congenital heart block (chb).The field representative believed the patient was feeling unwell due to the loss of rate response once the pacemaker entered safety mode.It was also likely the patient felt unwell due to oversensing and pacing inhibition of unipolar pacing.This pacemaker was explanted and replaced.No additional adverse patient effects were reported.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 bradycardia therapy remained available.The device was in safety mode when received and could not connect telemetry to test these allegations.With an external power supply the device functioned normally.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.However, probable cause could not be determined because the device is functioning normally and the battery has no failures.

• 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: 15196714
• MDR Text Key: 297569892
• Report Number: 2124215-2022-29885
• Device Sequence Number: 1
• Product Code: LWP
• 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: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/08/2018
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 235041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male