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

Model Number	V272
Medical Device Problem Codes	Signal Artifact/Noise (1036); Pacing Problem (1439)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) is pacing dependent and is a high impedance advisory device.The patient was checked in clinic today and the health care professional (hcp) programmed the device for safety mode simulation, confirming patient symptoms and device criteria for early device change-out.Technical services (ts) reviewed and discussed that early replacement is at the discretion of the following physician, and can be done at any point given the patient is on the advisory list and has symptoms during safety mode simulation.No adverse patient effects were reported.At this time, the device remains in service.

• Brand Name: INTUA
• 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: 13048319
• Report Number: 2124215-2021-35033
• Device Sequence Number: 11740494
• Product Code: NKE
• UDI-Device Identifier: 00802526536663
• UDI-Public: 00802526536663
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: 06/11/2016
• Device Model Number: V272
• Device Catalogue Number: V272
• Device Lot Number: 100211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female