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

Model Number V273

Device Problems Over-Sensing (1438); Pacing Problem (1439); Telemetry Discrepancy (1629)

Patient Problem Syncope/Fainting (4411)

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was difficult to interrogate.Additionally, the health care professional (hcp) stated the patient experienced pacing inhibition due to oversensing, leading into syncope.Technical services (ts) recommended a personal interrogation and during the follow-up the crt-p was found to be in safety mode.Subsequently, the device was explanted and replaced with a non boston scientific product.No additional adverse patient effects were reported.

• 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: 15304923
• MDR Text Key: 298725431
• Report Number: 2124215-2022-32807
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 101075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male