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

Model Number	4591
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited suspected loss of capture (loc) on the left ventricular (lv) lead channel.Technical services (ts) was consulted and noted possible fusion beats, however loc could not be discarded and further in office evaluation of the system was recommended.No adverse patient effects were reported.This system remains in service.
Additional Manufacturer Narrative
Additional information received from the field confirmed proper capture on this system.This complaint no longer meets reporting criteria.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited suspected loss of capture (loc) on the left ventricular (lv) lead channel.Technical services (ts) was consulted and noted possible fusion beats, however loc could not be discarded and further in office evaluation of the system was recommended.No adverse patient effects were reported.This system remains in service.Additional information was received indicating that proper capture was confirmed, and the suspected loc was due to fusion beats.No adverse patient effects were reported.This system remains in service.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22522764
• Report Number: 2124215-2025-47608
• Device Sequence Number: 20820991
• Product Code: LWP
• UDI-Device Identifier: 00802526422980
• UDI-Public: (01)00802526422980(17)101029
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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,Followup
• Report Date (Section B): 07/17/2025

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: 10/29/2010
• Device Model Number: 4591
• Device Catalogue Number: 4591
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 10/29/2008
• 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: 83 YR
• Patient Sex: Female