MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO? SR; PACEMAKER

Model Number	L100
Medical Device Problem Codes	Premature Discharge of Battery (1057); High impedance (1291); Over-Sensing (1438); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) suspected of this pacemaker battery to be depleting prematurely due to the battery longevity estimate calculations had decreased from two years to one year in about six months.A request was made to have data from this device analyzed.Technical services (ts) reviewed the stored device data and noted that a lead safety switch (lss) to unipolar configurations was triggered due to high out of range pacing impedances on the right ventricular (rv) lead.It was also noted the lead exhibited oversensing as well.Engineering analyzed the data and determined that the device battery was depleting normally, and the increase in power consumption appears to be due to be due to the increase in pacing impedances on the rv lead.At this time, the pacemaker and rv lead remain in service.No additional adverse patient effects were reported.
Additional 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 changes in 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.Engineering analysis and testing of returned products has determined that repeated, small movements of the lead terminal ring along with variances in the connection contact force and surface roughness can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurement.
Event or Problem Description
It was reported that during a clinic visit, the health care professional (hcp) suspected of this pacemaker battery to be depleting prematurely due to the battery longevity estimate calculations had decreased from two years to one year in about six months.A request was made to have data from this device analyzed.Technical services (ts) reviewed the stored device data and noted that a lead safety switch (lss) to unipolar configurations was triggered due to high out of range pacing impedances on the right ventricular (rv) lead.It was also noted the lead exhibited oversensing as well.Engineering analyzed the data and determined that the device battery was depleting normally, and the increase in power consumption appears to be due to be due to the increase in pacing impedances on the rv lead.At this time, the pacemaker and rv lead remain in service.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO? SR
• Common Device Name: 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: 22939529
• Report Number: 2124215-2025-61449
• Device Sequence Number: 9755771
• Product Code: LWP
• UDI-Device Identifier: 00802526558900
• UDI-Public: (01)00802526558900(17)170901
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2017
• Device Model Number: L100
• Device Catalogue Number: L100
• Device Lot Number: 705385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 09/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male