MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	N164
Medical Device Problem Codes	High impedance (1291); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661); Noise, Audible (3273)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	12/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) inappropriately delivered anti-tachycardia pacing (atp) and six shocks due to supraventricular tachycardia (svt).The ventricular rhythm surpassed the atrial rhythm due to cross chamber blanking.This crt-d remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) inappropriately delivered anti-tachycardia pacing (atp) and six shocks due to supraventricular tachycardia (svt).The ventricular rhythm surpassed the atrial rhythm due to cross chamber blanking.This crt-d remains in service.No additional adverse patient effects were reported.Additional information was received and this crt-d is exhibiting beeping.Technical services (ts) was consulted and found high out of range shock lead impedance measurements.Technical services (ts) recommended to continue to monitor the device.No additional adverse patient effects were reported.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 13376321
• Report Number: 2124215-2022-01942
• Device Sequence Number: 3452839
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 05/22/2022

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: 01/21/2016
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 105486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 05/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female