MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? STEERABLE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	4555
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead stated that this device had been accidentally bumped, leading to puffiness at the implant site.There were no additional adverse patient effects reported.As of this time, the lv lead remains in service.

• Brand Name: ACUITY? STEERABLE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 22778601
• Report Number: 2124215-2025-55900
• Device Sequence Number: 9341842
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: (01)00802526419447(17)140307
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/07/2014
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 202440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 03/07/2012
• 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: 68 YR
• Patient Sex: Male