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

Model Number L111

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

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

Event Date 03/31/2023

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.Device replacement and product return were recommended.This pacemaker remains in service at this time.No 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.Device replacement and product return were recommended.This pacemaker remains in service at this time.No adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

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 did not remain available.The device case was opened and the battery was removed and forwarded for detailed testing, which revealed no battery-related anomalies.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.Device replacement and product return were recommended.This pacemaker remains in service at this time.No adverse patient effects were reported.Additional information received reported that this pacemaker was explanted and replaced due to entering safety mode.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

• Brand Name: ESSENTIO 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: 16738242
• MDR Text Key: 313296940
• Report Number: 2124215-2023-17562
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558962
• UDI-Public: 00802526558962
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

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: 06/09/2018
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 235240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 07/26/2023; 12/27/2023
• Supplement Dates FDA Received: 08/21/2023; 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female