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

Model Number	4592
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Discomfort (2330)
Date of Event	04/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was part of a system revision due to pocket erosion and suspected possible infection.The patient described a hole in the skin at the device site, accompanied by significant bleeding, presence of pus discharge and pain upon touch.The primary care provider cleaned the site and scheduled a next-day follow-up.There were no additional adverse patient effects reported.This lv lead remains in service.

• 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: 25271747
• Report Number: 2124215-2026-27940
• Device Sequence Number: 9704077
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: (01)00802526423109(17)141102
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2026

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: 11/02/2014
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 144507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 11/02/2012
• 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: 73 YR
• Patient Sex: Female