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

Model Number	U125
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted during a lead changeout.There was an infection noted on the right atrial (ra) lead, which was surgically abandoned due to noisy signals.The left ventricular (lv) lead exhibited loss of capture (loc) after the atrial lead changeout and was subsequently explanted.The right ventricular (rv) lead was surgically abandoned due to noise and an upgrade to left bundle branch (lbb) pacing was desired by the physician.The brady lead for the lbb was not successfully implanted due to bent helix.A new lead was successfully placed.A new crt-p system was implanted successfully.This device has not been received for investigation.No additional adverse patient effects were reported.

• Brand Name: VALITUDE¿ CRT-P
• Common Device Name: cardiac resynchronization therapy pacemaker
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul 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 55112 ; +1(612)875-7234
• MDR Report Key: 50510331
• Report Number: 2124215-2026-46422
• Device Sequence Number: 21503127
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: (01)00802526559389(17)210314
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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
• Device Expiration Date: 03/14/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 712531
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/30/2026
• Date Device Manufactured: 04/11/2019
• 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: 51 YR
• Patient Sex: Female