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

Model Number	4592
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: with the available information, boston scientific concluded the clinical observation of failure to capture is a known inherent risk of the device and is noted within the product's instructions for use (ifu), as well as the product's risk documentation.Device technical analysis: this lead remains implanted.As such, physical analysis has not been conducted in our laboratory.This product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that the presenting electrogram (egm) of the cardiac resynchronization therapy defibrillator (crt-d) suggested that there was some left ventricular (lv) loss of capture; there was a second signal present on the lv egm that wasn't present on previous stored presenting egms.The lv auto threshold test was programmed off and the last measured threshold in (b)(6) 2020 was 0.6 v @ 1.0 ms.The current crt-d output was programmed at 1.5 v @ 1.0 ms.The physician was informed.The lv lead remains in service and no adverse patient effects were reported.Additional information received indicated that the crt-d recently alerted again for unsuccessful lv threshold testing due to fusion.The presenting egm showed intermittent loss of lv capture.Further review of the crt-d system was recommended.

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24849176
• Report Number: 2124215-2026-19681
• Device Sequence Number: 5624515
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: 00802526423109
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: P010012/S160
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 07/31/2015
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 147884
• 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: 03/15/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 07/07/2026
• Date Device Manufactured: 07/31/2013
• 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
• Patient Age: 71 YR
• Patient Sex: Unknown