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

Model Number	4592
Medical Device Problem Codes	High impedance (1291); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the proximal end of this left ventricular (lv) lead was surgically abandoned due to lead breakage during explant attempt.The extracted half of this lv lead was disposed.A new brady lead with a different model was placed in left bundle branch area.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the proximal end of this left ventricular (lv) lead was surgically abandoned due to lead breakage during explant attempt.The extracted half of this lv lead was disposed.A new brady lead with a different model was placed in left bundle branch area.No additional adverse patient effects were reported.Additional information indicated that the proximal end of this lv lead was extracted and disposed.This lv lead exhibited a single impedance measurement of more than 2000 ohms.
Additional Manufacturer Narrative
This report is being submitted to correct the device codes and patient codes fields (h6) in section h, device manufacturers only.
Event or Problem Description
It was reported that the proximal end of this left ventricular (lv) lead was surgically abandoned due to lead breakage during explant attempt.The extracted half of this lv lead was disposed.A new brady lead with a different model was placed in left bundle branch area.No additional adverse patient effects were reported.Additional information indicated that the proximal end of this lv lead was extracted and disposed.This lv lead exhibited a single impedance measurement of more than 2000 ohms.
Event or Problem Description
It was reported that the proximal end of this left ventricular (lv) lead was surgically abandoned due to lead breakage during explant attempt.The extracted half of this lv lead was disposed.A new brady lead with a different model was placed in left bundle branch area.No additional adverse patient effects were reported.Additional information indicated that the proximal end of this lv lead was extracted and disposed.This lv lead exhibited a single impedance measurement of more than 2000 ohms.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device because the primary reported observation is addressed in product labeling.Since the reported issues are covered by the instructions for use, it can be concluded that expected or well-understood factors most probably contributed to the event.This report is being submitted to correct the device codes and patient codes fields (h6) in section h, device manufacturers only.

• Brand Name: ACUITY SPIRAL
• 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: 24594905
• Report Number: 2124215-2026-14184
• Device Sequence Number: 18723570
• Product Code: LWP
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 08/26/2021
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 310779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 05/11/2026; 05/22/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/30/2026; 05/11/2026; 05/28/2026
• Date Device Manufactured: 08/26/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female