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

Model Number	4591
Medical Device Problem Codes	Failure to Capture (1081); Low impedance (2285); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited loss of capture and high thresholds.Additionally, it was noted that the lv pacing lead impedance measurements have decreased over the last year measuring from 550 ohms to 400-450 ohms.No observations of noise were found.The patient was brought into the clinic for further evaluation and the device was re-programmed.The programmer shows the longevity dropped from five years to three years with re-programming in which the health care professional (hcp) will consult with the physician.At this time, the lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited loss of capture and high thresholds.Additionally, it was noted that the lv pacing lead impedance measurements have decreased over the last year measuring from 550 ohms to 400-450 ohms.No observations of noise were found.The patient was brought into the clinic for further evaluation, and the device was re-programmed.The programmer shows the longevity dropped from five years to three years with re-programming in which the health care professional (hcp) will consult with the physician.At this time, the lead remains in service.No adverse patient effects were reported.Additional information was received which reported that this left ventricular (lv) lead was explanted and replaced successfully.No additional 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: 20956380
• Report Number: 2124215-2024-79965
• Device Sequence Number: 7584176
• Product Code: LWP
• UDI-Device Identifier: 00802526422980
• UDI-Public: 00802526422980
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• 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): 12/11/2025

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: 08/16/2012
• Device Model Number: 4591
• Device Catalogue Number: 4591
• Device Lot Number: 114476
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 08/16/2010
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male