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

Model Number G141

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/28/2024

Event Type  Injury  

Event Description

It was reported that this device delivered 4 inappropriate electric shocks and 26 inappropriate anti-tachycardia pacing (atp) due to an atrial arrythmia with rapid ventricular response (rvr).The device remains in service and reprograming was suggested.No additional adverse patient effects were reported.

• Brand Name: INOGEN CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 19143528
• MDR Text Key: 340598453
• Report Number: 2124215-2024-23879
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2024
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 152252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male