MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? X4 Straight; Implantable lead

Model Number	4672
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this left ventricular (lv) lead triggered an alert for high out-of-range pace impedance measurements greater than 2,000 ohms.It was noted that the patient had a recent therapy upgrade from an implantable cardioverter defibrillator (icd) to cardiac resynchronization therapy defibrillator (crt-d) system in (b)(6) 2026, and this lv lead was implanted at that time.Lv lead trends showed a rise in lv pace impedance measurements from 1,400 ohms in (b)(6) 2026, to a more recent measurement of 1,779 ohms.Left ventricular automatic threshold (lvat) tests were stable with measurements in the 1.2 to 1.4 v range, and there was no evidence of lv noise on these tests.Additionally, lv sensing was optimal.It was noted that the patient was seen in-clinic one week prior to the date of report.Technical services (ts) discussed troubleshooting options and programming considerations.This lv lead remains in service, and will continue to be monitored at this time.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ACUITY? X4 Straight
• 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: 25486764
• Report Number: 2124215-2026-31539
• Device Sequence Number: 18720846
• Product Code: LWP
• UDI-Device Identifier: 00802526524530
• UDI-Public: (01)00802526524530(17)270204
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 4672
• Device Catalogue Number: 4672
• Device Lot Number: 828324
• Was Device Available for Evaluation?: No
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 02/04/2025
• 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: 85 YR
• Patient Sex: Female