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

Model Number L301

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

Patient Problem Loss of consciousness (2418)

Event Date 12/04/2022

Event Type  Injury  

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this patient presented to the emergency room (er) and was noted to experience loss of consciousness.This pacemaker device was unable to be interrogated with a specific type of programmer used in the er.Boston scientific technical services (ts) discussed that it is possible the device is in safety mode as this programmer type does not have the ability to interrogate a device in safety mode.Ts also noted that the device will not response to a magnet when in safety mode.In addition, ts explained the device settings used by the device when in safety mode and noted that the patient appeared to be ventricular pace therapy dependent.The device was subsequently determined to have reverted to safety mode with limited critical therapy still available.Oversensing and associated pacing inhibition were observed due to the unipolar parameters used by the device in safety mode and is the likely cause of the reported loss of consciousness.The device was explanted and replaced the same day.No additional adverse patient effects were reported.

Event Description

It was reported that this patient presented to the emergency room (er) and was noted to experience loss of consciousness.This pacemaker device was unable to be interrogated with a specific type of programmer used in the er.Boston scientific technical services (ts) discussed that it is possible the device is in safety mode as this programmer type does not have the ability to interrogate a device in safety mode.Ts also noted that the device will not response to a magnet when in safety mode.In addition, ts explained the device settings used by the device when in safety mode and noted that the patient appeared to be ventricular pace therapy dependent.The device was subsequently determined to have reverted to safety mode with limited critical therapy still available.Oversensing and associated pacing inhibition were observed due to the unipolar parameters used by the device in safety mode and is the likely cause of the reported loss of consciousness.The device was explanted and replaced the same day.No additional adverse patient effects were reported.

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.This correction supplemental report was submitted with an additional code added to the impact codes table in report section h6.

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.This correction supplemental report was submitted with an additional code added to the impact codes table in report section h6.This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device could be interrogated and was confirmed to be operating in safety mode.Evidence of memory corruption was also noted.The device case was removed to facilitate inspection of the internal components and further testing.The battery was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short caused an increase in power consumption, which resulted in the memory errors identified in the laboratory setting and the clinically-observed reversion to safety mode operation.

Event Description

It was reported that this patient presented to the emergency room (er) and was noted to experience loss of consciousness.This pacemaker device was unable to be interrogated with a specific type of programmer used in the er.Boston scientific technical services (ts) discussed that it is possible the device is in safety mode as this programmer type does not have the ability to interrogate a device in safety mode.Ts also noted that the device will not response to a magnet when in safety mode.In addition, ts explained the device settings used by the device when in safety mode and noted that the patient appeared to be ventricular pace therapy dependent.The device was subsequently determined to have reverted to safety mode with limited critical therapy still available.Oversensing and associated pacing inhibition were observed due to the unipolar parameters used by the device in safety mode and is the likely cause of the reported loss of consciousness.The device was explanted and replaced the same day.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE 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: 15983536
• MDR Text Key: 305489473
• Report Number: 2124215-2022-52797
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2023

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: 11/04/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 723381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/18/2023; 06/06/2023
• Supplement Dates FDA Received: 01/18/2023; 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male