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

Model Number G148

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Connection Problem (2900); Device Sensing Problem (2917)

Patient Problems Syncope (1610); Fall (1848); Head Injury (1879)

Event Date 12/16/2018

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had an episode of syncope, during which they hit their head.They presented in-clinic the following day for a system evaluation.Noise could be reproduced on the right ventricular (rv) channel with isometrics.Rv impedance measurements were within range, but pacing inhibition of greater than two seconds occurred.A lead revision was planned.A boston scientific technical services (ts) consultant recommended that a tug test be performed during the procedure.During lead explant, an insulation breach was noted and blood was present in the rv port channel of this device, which was replaced concurrently.No additional adverse patient effects were reported.

Event Description

No additional information has been received.

• 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: 8597596
• MDR Text Key: 144655018
• Report Number: 2124215-2019-09826
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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: 12/21/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 162268
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR