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

Model Number	4678
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced muscle stimulation.Lv lead was reprogrammed to avoid stimulation.The representative called back and tested a few pacing options and it appears to be an rv issue.The outputs were at 4.5 v.Additionally, it was found out that the left ventricular (lv) lead impedance was at 700's ohms and then rose a couple of weeks ago.Engineering analysis was submitted.Analysis confirmed that there was a jump in the lv lead impedance and device power consumption and technical services (ts) suggested to options to program lv back to lv2_to_lv3 and see if the issues resolve or to treat this as a gate oxide malfunction and replace the pg and consider the possibility of lead damage via corrosion.To date, this device remains in service.No adverse patient effects were reported.

• 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: 24924688
• Report Number: 2124215-2026-21172
• Device Sequence Number: 15741479
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: (01)00802526524615(17)260220
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• 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): 07/10/2026

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 Expiration Date: 02/20/2026
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 813340
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 07/09/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/10/2026; 07/10/2026
• Date Device Manufactured: 02/21/2024
• 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: Male