MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)

Model Number L311

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem Dyspnea (1816)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this pacemaker had entered safety mode and the patient was experiencing shortness of breath.This pacemaker remains in service, however urgent device replacement and return for analysis was recommended.No additional adverse patient effects were reported.

Manufacturer Narrative

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 the patient was experiencing shortness of breath.This pacemaker remains in service, however urgent device replacement and return for analysis was recommended.No additional adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this pacemaker had entered safety mode and the patient was experiencing shortness of breath.This pacemaker remains in service, however urgent device replacement and return for analysis was recommended.No additional adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and returned for analysis.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 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.The product has been received for analysis.This report will be updated upon completion of analysis.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD)
• 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: 17368219
• MDR Text Key: 319503126
• Report Number: 2124215-2023-38663
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2023

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: 02/17/2019
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 280415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 09/07/2023; 11/16/2023
• Supplement Dates FDA Received: 09/26/2023; 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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: 74 YR
• Patient Sex: Male