MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST? X4 CRT-P; cardiac resynchronization therapy pacemaker (CRT-P)

Model Number	U228
Medical Device Problem Codes	Use of Device Problem (1670); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited a remote monitoring disabled (rmd) alert.Engineering analysis determined that the alert was very likely a false positive radio frequency (rf) disablement caused by magnet application during a loaded battery voltage measurement rather than an actual battery-related condition.Review of prior device data demonstrated normal loaded battery voltage measurements.A software update was recommended to restore telemetry functionality.No adverse patient effects were reported.This crt-p remains in service.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Boston scientific issued a field safety notice update to physicians regarding unintended behaviors observed with a software update designed to detect high battery impedance and prevent initiation of safety mode in accolade devices.The associated investigation determined that the software update led to this device experiencing a false positive response that resulted in disablement of the wandless telemetry.Boston scientific has developed a software update to address this unintended behavior.Boston scientific developed and released an additional software update for the accolade family designed to correct the unintended behaviors.This device exhibited the unintended behavior prior to receiving the additional software update.A risk review was completed and confirmed that the event of difficult to interrogate/telemetry (rf) 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.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to device design.

• Brand Name: VISIONIST? X4 CRT-P
• Common Device Name: cardiac resynchronization therapy pacemaker (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50869328
• Report Number: 2124215-2026-50659
• Device Sequence Number: 9425936
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: (01)00802526559471(17)270322
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 811929
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/03/2025
• 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: 81 YR
• Patient Sex: Female