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

Model Number G141

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Device Sensing Problem (2917)

Patient Problems Syncope (1610); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/29/2018

Event Type  Injury  

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 pacing impedances on the right ventricular (rv) lead connected to this device were intermittently high starting in september of 2018, eventually reaching out of range levels in november.There was also noise noted on the rv channel.This cardiac resynchronization therapy defibrillator (crt-d) was reprogrammed to increase the duration an episode must last before ventricular tachycardia is declared.No further interventions were reported.The rv lead and crt-d remain in service.No adverse patient effects were reported.

Event Description

Additional information was reported indicating that a loss of capture was observed and the patient was syncopal about five times since october.It was thought that this was a device issue.Thus, this crt-d was removed and replaced.This product has been returned.This report will be updated upon analysis completion.

Manufacturer Narrative

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.Pin gauge testing, designed to verify proper port dimensions, 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.This device passed all returned product testing; however, boston scientific has initiated an investigation into the behavior described in the event description, including consideration of potential design enhancements, as deemed appropriate.

• 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: 8581376
• MDR Text Key: 144123169
• Report Number: 2124215-2019-08402
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 120893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR