MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL L; IMPLANTABLE LEAD

Model Number	4678
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this brady lead was not successfully implanted due to lead breakage or fractured as the helix did not exhibit normal behavior.Additionally, a wire perforated through the lead, and this brady lead had to be discarded.Then a new brady lead of a different model was successfully implanted.The brady lead was returned for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental report was created to capture the revisions to the initial mdr in block b5 (event description) and blocks f10 and h6 (device code).
Event or Problem Description
It was reported that this brady lead was not successfully implanted due to the wire perforated through the lead.A new brady lead of a different model was successfully implanted.The brady lead was returned for analysis.No adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL L
• 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: 24473443
• Report Number: 2124215-2026-11138
• Device Sequence Number: 13327559
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: (01)00802526524615(17)270414
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2026

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: Health Professional
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 816351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 06/24/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/27/2026; 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: 86 YR
• Patient Sex: Male