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

Model Number	N164
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	11/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals, oversensing, and pacing inhibition greater than 2 seconds on the right ventricular (rv) lead.Additionally, it was noted a very gradual decrease in rv pacing and shock impedance measurements.Troubleshooting options were discussed.At this time, the product remains in service and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe the event or problem field d6b: explant date h1: type of reportable event h6: impact codes additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals, oversensing, and pacing inhibition greater than 2 seconds on the right ventricular (rv) lead.Additionally, it was noted a very gradual decrease in rv pacing and shock impedance measurements.Troubleshooting options were discussed.A revision procedure was performed and the device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noisy signals, oversensing, and pacing inhibition greater than 2 seconds on the right ventricular (rv) lead.Additionally, it was noted a very gradual decrease in rv pacing and shock impedance measurements.Troubleshooting options were discussed.A revision procedure was performed and the device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe the event or problem field d6b: explant date h1: type of reportable event h6: impact codes additionally, the product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.

• 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: 16043279
• Report Number: 2124215-2022-54796
• Device Sequence Number: 5237678
• Product Code: LWP
• UDI-Device Identifier: 00802526481031
• UDI-Public: 00802526481031
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/02/2015
• Device Model Number: N164
• Device Catalogue Number: N164
• Device Lot Number: 103733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/27/2022; 01/24/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 01/16/2023; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male