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

Model Number G141

Device Problem High impedance (1291)

Patient Problem Complete Heart Block (2627)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that a check right ventricular (rv) lead message had been generated for this system.A review of the data identified spikes in the rv pacing impedance measurements with two measurements out of range and greater than 2000 ohms.There were no stored episodes of noise.A boston scientific technical services consultant discussed the clinical observations with the caller who stated they will continue to monitor this patient for potential future issues that could arise with the out of range impedance measurements, oversensing due to interaction with minute ventilation (mv).No adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

This supplemental report is being filed to update the investigation conclusion code and additional manufacturing narrative.

• Brand Name: INOGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9100023
• MDR Text Key: 159449756
• Report Number: 2124215-2019-18662
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2020
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 130004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• Patient Sequence Number: 1
• Patient Age: 57 YR