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

Model Number	4592
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) system experienced a syncopal episode and was admitted to the hospital.A device evaluation was performed, during which shock lead impedance measurements were found to be high out of range.Additionally, pacing impedance measurements on the right ventricular (rv), right atrial (ra), and left ventricular (lv) leads were noted to be elevated but remained within normal limits.Evaluation of the electrolyte levels for the patient revealed fluctuations, and it was suspected that the impedance changes were related to physiological factors rather than a device or lead anomaly.The plan was to continue monitoring the patient.This lv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This lead remains implanted and in-service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 25513254
• Report Number: 2124215-2026-31936
• Device Sequence Number: 10014389
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: (01)00802526423109(17)161120
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: 11/20/2016
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 304002
• 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: 05/20/2026
• Initial Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 11/20/2014
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male