MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO DR; IMPLANTABLE DEVICE

Model Number L101

Device Problems Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581); Under-Sensing (1661)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the pacemaker had stored episodes of pacemaker mediated tachycardia (pmt) and undersensing of atrial flutter due to cross chamber blanking periods.Technical services (ts) was contacted, and ts discussed programming options, noting the cross chamber blanking was programmed due to far-field oversensing of ventricular signals on the atrial channel.The pacemaker and non-boston scientific leads remain in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO DR
• Type of Device: IMPLANTABLE DEVICE
• 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: 18842982
• MDR Text Key: 337013866
• Report Number: 2124215-2024-13620
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2018
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 746403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• 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 Age: 90 YR
• Patient Sex: Male