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

Model Number	4592
Medical Device Problem Codes	Fracture (1260); High Capture Threshold (3266)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited high threshold output.Ultimately, this lv lead was attempted to be extracted during which the lead broke.Part of the lead was extracted and part of it remains in the patient.A new lv lead was implanted and remains in service.The part of this lv lead that was explanted has been returned and is expected to be analyzed.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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25673472
• Report Number: 2124215-2026-34906
• Device Sequence Number: 21444638
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: (01)00802526423109(17)150411
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 04/11/2015
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 146253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 04/11/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female