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

Model Number G141

Device Problems Signal Artifact/Noise (1036); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was suspected to exhibit set screw issues.Intermittent noise was observed on the right atrial (ra) lead.The involved lead is a non boston scientific product.The field representative stated a possible atrial lead revision would be performed soon.No adverse patient effects were reported.At this time, this device system remains in service.

• Brand Name: INOGEN CRT-D
• Type of Device: 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: 18321503
• MDR Text Key: 330406963
• Report Number: 2124215-2023-70848
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2017
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 112888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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 Age: 72 YR
• Patient Sex: Male