MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? STEERABLE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	4554
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called for review of a presenting electrogram (egm).Technical services (ts) reviewed the data and found there is intermittent left ventricular (lv) loss of capture.Additionally, the lv impedances have increased from 400 ohms range to over 1,456 ohms over the past year.Ts recommended further testing of the lv lead.At this time, the lead remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the health care professional (hcp) called for review of a presenting electrogram (egm).Technical services (ts) reviewed the data and found there is intermittent left ventricular (lv) loss of capture.Additionally, the lv impedances have increased from 400 ohms range to over 1,456 ohms over the past year.Ts recommended further testing of the lv lead.At this time, the lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Added device code a070101.The 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? STEERABLE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 21344559
• Report Number: 2124215-2025-07016
• Device Sequence Number: 20796938
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: (01)00802526419324(17)111209(21)180323
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 04/28/2026

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: 12/09/2011
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 180323
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 12/09/2009
• 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: 72 YR
• Patient Sex: Male