MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number V273

Device Problems Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Syncope/Fainting (4411)

Event Date 12/06/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) had experienced syncope.The crt-p had entered safety mode.Oversensing was reported.This device was explanted and replaced.This crt-p has not returned for analysis.No additional adverse patient effects were reported.

• Brand Name: INTUA
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• 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: 18303788
• MDR Text Key: 330189601
• Report Number: 2124215-2023-70137
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 101156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male