MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G148

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Syncope (1610)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

It was reported the cardiac resynchronization therapy defibrillator (crt-d) exhibited noise on the right ventricular (rv) channel.The noise was oversensed and resulted in pacing inhibition of greater than 2 seconds and caused the patient to experience a syncopal episode.The patient noted that the device moves around quite a bit when sleeping, which is when the noise episodes have occurred.The noise could not be reproduced with isometrics or pocket manipulation.At this time, the sensitivity has been adjusted.Further testing may be performed in the future.No additional adverse patient effects were reported.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

This supplemental report is being filed to provide additional information.The patient was brought in for defibrillation threshold (dft) testing and the device did not sense the ventricular fibrillation, so the patient had to be rescued externally.The patient was fitted for a lifevest for monitoring until a revision could be scheduled.The crt-d was explanted and the rv lead was surgically abandoned.Both products were successfully replaced.The rv lead was suspected to be fractured as there was evidence of clavicular/first rib crush damage.The lead was initially attempted to be extracted, but was ultimately abandoned.No additional adverse patient effects were reported.

Event Description

This report is being filed to submit the analysis results.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection 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.

• Brand Name: INOGEN X4 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: 8718515
• MDR Text Key: 148667036
• Report Number: 2124215-2019-10531
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• 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,Followup
• Report Date: 09/19/2019

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: 10/22/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 110161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 05/24/2019; 09/12/2019
• Supplement Dates FDA Received: 08/01/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR