MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? X4 SPIRAL L; IMPLANTABLE LEAD

Model Number	4678
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this left ventricular (lv) lead presented a lead safety switch (lss) due to a high out of range pace impedance measurement.Technical services (ts) reviewed the lead trend and noted stable impedance variability from 1500 to 1900 ohms since implant.Ts also noted that the specified impedance range for this lead was 200 to 3000 ohms.Ts provided programming recommendations and suggested increasing the out of range threshold to 3000 ohms.No adverse patient effects were reported.This lv lead remains in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This lead remains implanted and in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that this left ventricular (lv) lead presented a lead safety switch (lss) due to a high out of range pace impedance measurement.Technical services (ts) reviewed the lead trend and noted stable impedance variability from 1500 to 1900 ohms since implant.Ts also noted that the specified impedance range for this lead was 200 to 3000 ohms.Ts provided programming recommendations and suggested increasing the out of range threshold to 3000 ohms.No adverse patient effects were reported.This lv lead remains in service.Additional information was received.This lv lead exhibited another lss due to a high out of range pace impedance measurement.As a result of the lss, sensing was set to unipolar configuration.The health care professional (hcp) observed noise on the lv channel; however, the noise was not being sensed.Ts provided additional programming recommendations.No adverse patient effects were reported.This lv lead remains in service.

• Brand Name: ACUITY? X4 SPIRAL L
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24192856
• Report Number: 2124215-2026-04790
• Device Sequence Number: 15421091
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: (01)00802526524615(17)270611
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/20/2026

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 Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 816679
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 06/11/2025
• 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: 83 YR
• Patient Sex: Male