MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE?; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	V173
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Inaccurate Synchronization (1609)
Health Effect - Clinical Codes	Bradycardia (1751); Ventricular Fibrillation (2130)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) went into ventricular fibrillation (vf) during a generation change procedure.Technical services (ts) reviewed device data and noted a pause in heart rate prior to electrocautery noise on both the right atrial and right ventricular channels.Ts noted that the patient's rhythm was likely already in an arrhythmia, however recommended physician review to confirm, but the cause was not determined.The patient was continuously monitored at the hospital to resolve.This device was subsequently explanted and replaced due to normal battery depletion.No additional adverse patient effects were reported.

• Brand Name: INVIVE?
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22954379
• Report Number: 2124215-2025-61867
• Device Sequence Number: 9894087
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: (01)00802526536632(17)160606
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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: 06/06/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106556
• 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: 08/15/2025
• Initial Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 06/17/2014
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Male