MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? X4 Spiral S; Implantable Lead

Model Number	4675
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
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 triggered a lead safety switch (lss) from bipolar to unipolar configurations due to pacing impedances measurement of 2003 ohms which is considered to be high out of range.Technical services (ts) was consulted for review and provided programming recommendations.At this time, no immediate patient impact or adverse effects were reported.This lv lead remains in service.
Event or Problem Description
It was reported that this left ventricular (lv) lead triggered a lead safety switch (lss) from bipolar to unipolar configurations due to pacing impedances measurement of 2003 ohms which is considered to be high out of range.Technical services (ts) was consulted for review and provided programming recommendations.At this time, no immediate patient impact or adverse effects were reported.This lv lead remains in service.Subsequent additional information was received indicated that a replacement procedure was later performed.This lv lead was explanted and replaced with a new lead successfully.No additional adverse patient effects were reported.This lv lead was returned to facility and is awaiting analysis.
Additional Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: ACUITY? X4 Spiral S
• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25130208
• Report Number: 2124215-2026-25219
• Device Sequence Number: 9293030
• Product Code: LWP
• UDI-Device Identifier: 00802526524578
• UDI-Public: (01)00802526524578(17)280125
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 841945
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/12/2026; 08/27/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/26/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male