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

Model Number V272

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439)

Patient Problem Discomfort (2330)

Event Date 10/04/2021

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 282561371
• Report Number: 2124215-2021-35033
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536663
• UDI-Public: 00802526536663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Sex: Female