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

Model Number	N164
Medical Device Problem Codes	High impedance (1291); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device exhibited high impedance measurements on the left ventricular (lv) channel.Upon review, technical services (ts) stated that there was an abrupt rise in the impedances with measurements at 1425 ohms.There was also decrease in intrinsic amplitude which were noted high earlier.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report contains correction in entire section e of initial reporter and section g2 report source.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) device exhibited high impedance measurements on the left ventricular (lv) channel.Upon review, technical services (ts) stated that there was an abrupt rise in the impedances with measurements at 1425 ohms.There was also decrease in intrinsic amplitude which were noted high earlier.This device remains in service.No adverse patient effects were reported.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D)
• 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: 19351860
• Report Number: 2124215-2024-30512
• Device Sequence Number: 7431401
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: 12/02/2015
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 105320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male