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

Model Number	4591
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Unspecified Infection (1930)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead had endocarditis.There were no additional adverse patient effects reported.The lv lead remains in service.
Additional Manufacturer Narrative
This supplemental report was created to update the entry in d4: serial number.
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead had endocarditis.There were no additional adverse patient effects reported.The lv lead remains in service.
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead had endocarditis.There were no additional adverse patient effects reported.The lv lead remains in service.Additional information indicates that the left ventricular (lv) lead was explanted due to endocarditis.There were no additional adverse patient effects reported.
Additional Manufacturer Narrative
This supplemental report was created to update the entry in h6: patient codes, h6: impact codes and d6b: explant date.This supplemental report was created to update the entry in d4: serial number.

• 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: 24419419
• Report Number: 2124215-2026-09886
• Device Sequence Number: 12231901
• Product Code: LWP
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• 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): 07/08/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/16/2016
• Device Model Number: 4591
• Device Catalogue Number: 4591
• Device Lot Number: 302692
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 06/18/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/03/2026; 07/08/2026
• Date Device Manufactured: 12/16/2014
• 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: 72 YR
• Patient Sex: Male