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

Model Number	4554
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Palpitations (2467); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted and replaced due to a nonspecific product performance anomaly.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated f10: patient codes.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted and replaced due to a nonspecific product performance anomaly.No additional adverse patient effects were reported.Additional information was received stating this lv lead was explanted due to severe palpitations and anomalies related to pacing.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: 24933923
• Report Number: 2124215-2026-21417
• Device Sequence Number: 10671302
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: (01)00802526419324(17)110313
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 03/13/2011
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 173994
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 03/13/2009
• 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: 42 YR
• Patient Sex: Female