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

Model Number L311

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  Injury  

Event Description

It was reported that this pacemaker device was found to be in safety mode with limited critical therapy still available.It was indicated that this patient is not known to be pace therapy dependent.Boston scientific technical services (ts) provided guidance that the device is malfunctioning, it should be replaced as soon as possible and returned for analysis.Ts also discussed the precautions and risks with the non-programmable device settings when in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Information indicates this device will be returned for analysis.This investigation will be updated should further information be provided.

Event Description

It was reported that this pacemaker device was found to be in safety mode with limited critical therapy still available.It was indicated that this patient is not known to be pace therapy dependent.Boston scientific technical services (ts) provided guidance that the device is malfunctioning, it should be replaced as soon as possible and returned for analysis.Ts also discussed the precautions and risks with the non-programmable device settings when in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.Additional information was provided that once the pacemaker device had reverted to safety mode, the patient was feeling discomfort from the unipolar right ventricular pace settings.No additional adverse patient effects were reported.

Manufacturer Narrative

Information indicates this device will be returned for analysis.This investigation will be updated should further information be provided.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.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 device was found to be in safety mode with limited critical therapy still available.It was indicated that this patient is not known to be pace therapy dependent.Boston scientific technical services (ts) provided guidance that the device is malfunctioning, it should be replaced as soon as possible and returned for analysis.Ts also discussed the precautions and risks with the non-programmable device settings when in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.Additional information was provided that once the pacemaker device had reverted to safety mode, the patient was feeling discomfort from the unipolar right ventricular pace settings.No additional adverse patient effects were reported.

• 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: 15946264
• MDR Text Key: 305138191
• Report Number: 2124215-2022-51644
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

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: 06/23/2018
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 238271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 07/14/2023
• Supplement Dates FDA Received: 12/09/2022; 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female