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

Model Number L101

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Telemetry Discrepancy (1629); Inappropriate or Unexpected Reset (2959)

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

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that the patient implanted with this pacemaker had observed yellow collecting waves on their communicator, and patient-initiated interrogation (pii) were unsuccessful.A few days later, it was determined that this pacemaker had entered safety mode.Upon interrogation, the following codes were noted: 0x12 0xf 0xe.Technical services (ts) discussed troubleshooting options, recommending emergent device replacement and product return for analysis.Additional information received reported that this pacemaker was explanted and replaced with another manufacturer's device.No additional adverse patient effects were reported.This product is expected to be returned by the explanting facility.

Manufacturer Narrative

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

• Brand Name: ESSENTIO 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: 18966071
• MDR Text Key: 338430794
• Report Number: 2124215-2024-17635
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: 00802526558924
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2020
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 768082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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: 76 YR
• Patient Sex: Male