MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE? X4 CRT-P; Implantable Cardiac Resynchronization Therapy Pacemaker

Model Number	U128
Medical Device Problem Codes	Nonstandard Device (1420); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon completion of the product analysis, this device was confirmed to have been operating in safety mode.The device was confirmed to be able to perform a memory dump, and it never triggered the elective replacement indicator.No additional adverse patient effects were reported.This device is no longer in service.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high battery impedance, which put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to enter safety mode operation to maintain back-up pacing with pre-defined settings.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade family pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.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.

• Brand Name: VALITUDE? X4 CRT-P
• Common Device Name: Implantable Cardiac Resynchronization Therapy Pacemaker
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50899310
• Report Number: 2124215-2026-51233
• Device Sequence Number: 18817967
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)191120
• 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: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 11/20/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 727120
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2017
• 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: Female