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

Model Number	4555
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Bacterial Infection (1735); Cough (4457)
Date of Event	12/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system which included a left ventricular (lv) lead, a right ventricular (rv) lead, and a non boston scientific right atrial (ra) lead was scheduled for laser lead extraction by the physician after presenting to the emergency room with cough and congestion and later being found to have an infection with e.Faecalis bacteremia, for which antibiotics were initiated.A transesophageal echocardiogram (tee) demonstrated vegetation on the ra lead, and lead extraction was recommended.The device clinic report also noted that the lv lead was exhibiting high out of range pacing impedance greater than 3000 ohms.The entire system was subsequently explanted via laser lead extraction, with no additional adverse patient effects reported.The next course of action is patient recovery and resolution of the infection prior to reimplantation.The system was retained by the customer.

• 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: 24205663
• Report Number: 2124215-2026-05191
• Device Sequence Number: 13225464
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: (01)00802526419447(17)130413
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/13/2013
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 196586
• 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: 01/22/2026
• Initial Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 04/13/2011
• 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; Other; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male