MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL L; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	4678
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while preparing this cardiac resynchronization therapy defibrillator (crt-d) system for a magnetic resonance imaging (mri) scan, high out-of-range left ventricular (lv) lead pace impedance measurements greater than 2,000 ohms were observed.A vector breakdown showed high out-of-range pace impedance measurements for most vectors including lv1.The lv lead was reprogrammed to lv2-lv3 where stable, in-range impedances were observed in the 1,265-1,295 ohms range.The field representative planned to consult with the health care professional (hcp) for further guidance.Additional information received reported that the mri was completed without issues.This lv lead remains in service and will continue to be monitored via normal follow-ups.No adverse patient effects were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the event cause, but further information was unable to be obtained.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.Correction to e1: initial reporter details updated.
Event or Problem Description
It was reported that while preparing this cardiac resynchronization therapy defibrillator (crt-d) system for a magnetic resonance imaging (mri) scan, high out-of-range left ventricular (lv) lead pace impedance measurements greater than 2,000 ohms were observed.A vector breakdown showed high out-of-range pace impedance measurements for most vectors including lv1.The lv lead was reprogrammed to lv2-lv3 where stable, in-range impedances were observed in the 1,265-1,295 ohms range.The field representative planned to consult with the health care professional (hcp) for further guidance.Additional information received reported that the mri was completed without issues.This lv lead remains in service and will continue to be monitored via normal follow-ups.No adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL L
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 23158694
• Report Number: 2124215-2025-68182
• Device Sequence Number: 17478345
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: (01)00802526524615(17)221005
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/05/2026

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: 10/04/2022
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 806268
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 10/04/2020
• 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: 63 YR
• Patient Sex: Unknown