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

Model Number	4554
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced sensation near the device and down the lead.Touching and pressing the area feels like an electrical shock.Boston scientific technical services (ts) discussed that it was a possible insulation exposure resulting in stimulation.The whole system was explanted due to infection.No additional 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 patient code (b)(6).A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of damaged/defective was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.The device was not returned for analysis; 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.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced sensation near the device and down the lead.Touching and pressing the area feels like an electrical shock.Boston scientific technical services (ts) discussed that it was a possible insulation exposure resulting in stimulation.The whole system was explanted due to infection.No additional adverse patient effects were reported.

• 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: 21806153
• Report Number: 2124215-2025-21987
• Device Sequence Number: 8834670
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: (01)00802526419324(17)110423
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 04/23/2011
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 175488
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 04/23/2009
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male