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

Model Number	4592
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Malaise (2359)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) requested technical services (ts) for further review of the presenting electrogram (egm) due to concerns of loss of capture (loc) on the left ventricular (lv) lead.It was noted that the patient reported of not feeling well.Ts reviewed the egm and discussed findings with the hcp recommending for in person clinic visit for further evaluation.At this time, the lv lead remains in service.No adverse patient effects were reported.

• 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: 22760422
• Report Number: 2124215-2025-55569
• Device Sequence Number: 9805386
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: (01)00802526423109(17)131108
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: Lay User/Patient
• Device Expiration Date: 11/08/2013
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 138476
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 11/08/2011
• 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 Sex: Male