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

Model Number	4592
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited high pacing threshold.The lead was partially explanted and a portion remains implanted.A new lead was implanted.No additional adverse patient effects were reported.

• Brand Name: ACUITY SPIRAL
• 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: 23971099
• Report Number: 2124215-2026-00540
• Device Sequence Number: 9295565
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: (01)00802526423109(17)160116
• 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: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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 Expiration Date: 01/16/2016
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 150306
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 01/16/2014
• 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: 64 YR
• Patient Sex: Female