MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE CRT-P; Implantable Device

Model Number	U125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an infection of the cardiac resynchronization therapy pacemaker (crt-p) system and underwent an explant procedure of all components on (b)(6) 2026.The procedure started with extraction of the lead that was placed for left bundle branch area pacing.Minimal laser was required and the lead was successfully removed.Next, the atrial lead was extracted and during removal a loss of capture occurred on the temporary right ventricular (rv) pacing lead due to the lead catheter being pulled on.The patient was noted to be dependent, with no underlying rhythm.The healthcare provider (hcp) moved to adjust the temporary pacing device and inadvertently caught his foot on the laser equipment and pulled on the atrial lead, dislodging it from the heart.At the same time another hcp was able to increase the output on the temporary device.After the atrial lead was extracted the patient's blood pressure began to drop when capture was lost.Medication was administered and the patient underwent a transesophageal echocardiogram (tee) to examine the heart and no issues were observed.Once the patient's bp was stabilized, and capture with the temporary rv lead was confirmed, the existing right ventricular (rv) lead was extracted.The extraction was successful; however, during removal the laser lead catheter was hooking onto the temporary pacing lead and so it was decided to add another temporary pacing lead for patient safety.After several minutes the device pocket area was closed, and the team began to prepare the patient for a semi-permanent pacemaker and the patient's bp dropped into the 40's.The cardiothoracic surgical team was called stat, and the staff began chest compressions.The patient's chest was opened but ultimately the patient did not survive.All system components were sent to the hospital pathology department per protocol and thus won't be returned.
Additional Manufacturer Narrative
Investigation summary/conclusion: with the available information, boston scientific concluded the clinical observation of infection is a known inherent risk of the device and is noted within the product's instructions for use (ifu), as well as the product's risk documentation.

• Brand Name: VALITUDE CRT-P
• Common Device Name: Implantable Device
• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50248282
• Report Number: 2124215-2026-43664
• Device Sequence Number: 15970216
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: (01)00802526559389(17)250209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/09/2025
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 725077
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 02/23/2023
• 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 Sex: Male