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

Model Number	4555
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this previously capped left ventricular (lv) lead was part of the system revision due to infection.No adverse patient effects were reported.The previously capped lv lead was explanted.
Additional Manufacturer Narrative
This supplemental report is being filed to correct the b5: description of the event; d9: device avail for eval; d9: device return date; g2: report source; h2: follow-up type; h3: device eval by manufacturer; h6: patient code; and h11: additional mfr narrative.
Event or Problem Description
It was reported that this previously capped left ventricular (lv) lead was part of the system revision due to infection.No adverse patient effects were reported.The previously capped lv lead was explanted.Additional information indicated that the system was explanted due to systemic infection and pocket erosion.Furthermore, the explanted system was returned for analysis.No additional adverse patient effects were reported.

• Brand Name: ACUITY STEERABLE
• 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: 23161816
• Report Number: 2124215-2025-68284
• Device Sequence Number: 9555563
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: (01)00802526419447(17)100502
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 03/10/2026

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: 05/02/2010
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 168426
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 05/02/2008
• 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: Male