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

Model Number L101

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

It was reported that this pacemaker, implanted with another manufacturer's right ventricular (rv) lead, triggered a lead safety switch (lss) due to a high out-of-range pace impedance measurement greater than 2,000 ohms, and it was suspected to have been attributed to the device header to lead spring contact connection.It was noted that the patient was pacer dependent, however there was no evidence of noise on the presenting or stored electrograms (egms).Technical services (ts) reviewed troubleshooting options and programming considerations.This pacemaker system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this pacemaker, implanted with another manufacturer's right ventricular (rv) lead, triggered a lead safety switch (lss) due to a high out-of-range pace impedance measurement greater than 2,000 ohms, and it was suspected to have been attributed to the device header to lead spring contact connection.It was noted that the patient was pacer dependent, however there was no evidence of noise on the presenting or stored electrograms (egms).Technical services (ts) reviewed troubleshooting options and programming considerations.This pacemaker system remains in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO DR
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 18813239
• MDR Text Key: 336989582
• Report Number: 2124215-2024-12412
• 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,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2019
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 758956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2017
• 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 Age: 75 YR
• Patient Sex: Female