MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? Spiral; Implantable lead

Model Number	4592
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Device Overstimulation of Tissue (1991); Pericardial Effusion (3271)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited increased in threshold measurements as per current capture.Neither vector had a threshold below 4 volts at 1 milli second.In addition, at the higher outputs; the patient experienced stimulation.The lv lead was set to 5 volts at 1 milli second output tip to right ventricular (rv) lead.As of this time, this lv lead remains in service.No adverse patient effects were reported.Additional information received indicates that this lv lead was explanted.During lead removal, the patient's blood pressure (bp) dropped, and a pericardial drain was placed.A new lead was then implanted; however, the bp remained unstable.A thoracotomy was performed, and upon opening the chest, a tear was identified in the mid coronary sinus (cs).The newly placed lead was pulled back during head rotation.The surgeon subsequently implanted two epicardial leads.Additionally, the ra lead demonstrated minimal sensing and is currently non-capturing, likely due to the surgical cannula.

• 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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25460172
• Report Number: 2124215-2026-30961
• Device Sequence Number: 8708883
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: (01)00802526423109(17)141016
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 10/16/2014
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 144215
• 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: 05/22/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 10/16/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female