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

Model Number	4554
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a generator change procedure, this left ventricular (lv) lead exhibited intermittent loss of capture (loc) and high pacing thresholds.Under fluoroscopy the lead appeared to have perforated in the epicardial space.The physician opted to surgically abandon the lv lead and replaced it with a new lead successfully.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; 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: 21560566
• Report Number: 2124215-2025-14523
• Device Sequence Number: 13065370
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: 00802526419324
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: 04/29/2016
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 198376
• 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: 02/19/2025
• Initial Report FDA Received Date: 03/10/2025
• Date Device Manufactured: 04/29/2014
• 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; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Male