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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information regarding the patient alleged lead issue.At this time, no additional information could be provided by the local area sales representative or is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system called technical services (ts) stating that "a lead is not connecting or working correctly." the patient was unable to expound on the issue observed nor which lead was affected.Ts referred the patient to consult with the device treating clinic for further assistance.At this time, no additional adverse effects were reported.The right atrial (ra), right ventricular (rv), and left ventricular (lv) leads remain in service.

• 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: 22349829
• Report Number: 2124215-2025-42912
• Device Sequence Number: 8519804
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: (01)00802526419447(17)160626
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/26/2016
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 216423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 06/26/2014
• 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
• Patient Age: 63 YR
• Patient Sex: Male