MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number	V273
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Defective Device (2588)
Health Effect - Clinical Codes	Heart Block (4444); Insufficient Information (4580)
Date of Event	11/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Dimensional analysis of the header was completed.Each port measured as expected.Rv pace sense test was performed which passed and verified that a pacing signal was present.Interrogation of the device confirmed it was operating in safety mode and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption (during telemetry or other higher power device operations) and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited oversensing on the right ventricular (rv) lead channel which led to pacing inhibition, which lasted less than two seconds.No additional adverse patient effects were reported.This device was explanted due to normal battery depletion.

• Brand Name: INTUA
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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: 21696508
• Report Number: 2124215-2025-18597
• Device Sequence Number: 9281798
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 09/01/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 101393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2016-2021
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male