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

Model Number	U125
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	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the communicator of this cardiac resynchronization therapy pacemaker (crt-p) displayed a yellow collecting wave.Technical services (ts) recommended working with the clinic to verify the radio frequency (rf) settings in the device.It was noted the patient was seen in the clinic approximately one week later and a patient-initiated interrogation (pii) was attempted, and the yellow collecting wave was still present.While in the clinic, it was determined that rf had been disabled.It was suspected the patient likely got the newest software update when they were seen in the clinic approximately four months ago, and rf disabled with the first measurement taken by the new algorithm, which is why there was no alert.It was noted the patient would be scheduled for a device change out.No adverse patient effects were reported.This crt-p remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: VALITUDE? 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 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: 50914865
• Report Number: 2124215-2026-51380
• Device Sequence Number: 5394579
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: (01)00802526559389(17)180824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 08/24/2018
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 703410
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 09/06/2016
• 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 Sex: Male