MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	N161
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Diarrhea (1811); Vomiting (2144); Dizziness (2194); Malaise (2359); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) system revealed oversensed noise with pacing inhibition on the right ventricular (rv) lead channel.Technical services (ts) states that the noise looked like electromagnetic interference (emi), as the signals were too fast for mypotential noise.The patient does not recall what they were doing at the time of the episode, and no further episodes have been stored.All lead measurements are within normal limits.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d system remains in service, and will continue to be monitored at this time.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) system revealed oversensed noise with pacing inhibition on the right ventricular (rv) lead channel.Technical services (ts) states that the noise looked like electromagnetic interference (emi), as the signals were too fast for mypotential noise.The patient does not recall what they were doing at the time of the episode, and no further episodes have been stored.All lead measurements are within normal limits.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d system remains in service, and will continue to be monitored at this time.No adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy defibrillator (crt-d) system stored another episode with similar noise observed on the right ventricular (rv) lead channel, and electromagnetic interference (emi) was suspected.At the time of the previous episode in october, the patient reported dizziness, feeling sick, vomiting, and diarrhea.The patient was scheduled for a follow up visit.This crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) system revealed oversensed noise with pacing inhibition on the right ventricular (rv) lead channel.Technical services (ts) states that the noise looked like electromagnetic interference (emi), as the signals were too fast for mypotential noise.The patient does not recall what they were doing at the time of the episode, and no further episodes have been stored.All lead measurements are within normal limits.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d system remains in service, and will continue to be monitored at this time.No adverse patient effects were reported.Additional information received reported that this cardiac resynchronization therapy defibrillator (crt-d) system stored another episode with similar noise observed on the right ventricular (rv) lead channel, and electromagnetic interference (emi) was suspected.At the time of the previous episode in october, the patient reported dizziness, feeling sick, vomiting, and diarrhea.The patient was scheduled for a follow up visit.This crt-d remains in service.No additional adverse patient effects were reported.According to additional information this crt-d was explanted at the physician's discretion for a therapy upgrade.No additional adverse patient effects were reported outside of replacement procedure.

• Brand Name: INCEPTA CRT-D
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 17990357
• Report Number: 2124215-2023-58832
• Device Sequence Number: 7428961
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: 00802526481000
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 03/21/2024

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: 01/02/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 499973
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 03/12/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 01/05/2024; 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• 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: 40 YR
• Patient Sex: Male