MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G140
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) was requested due to the patient experiencing palpitations.Upon review, technical services (ts) noted possible right atrial (ra) lead loss of capture (loc).Ts reviewed troubleshooting options, and ra lead evaluation was recommended.This crt-d system 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.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.Correction to h6: updated patient coding to include palpitations.
Event or Problem Description
It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) was requested due to the patient experiencing palpitations.Upon review, technical services (ts) noted possible right atrial (ra) lead loss of capture (loc).Ts reviewed troubleshooting options, and ra lead evaluation was recommended.This crt-d system remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 18490398
• Report Number: 2124215-2024-01141
• Device Sequence Number: 3533574
• Product Code: NIK
• UDI-Device Identifier: 00802526534539
• UDI-Public: 00802526534539
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 01/30/2017
• Device Model Number: G140
• Device Catalogue Number: G140
• Device Lot Number: 476807
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2015
• 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: 83 YR
• Patient Sex: Male