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

Model Number G148

Device Problems Premature Discharge of Battery (1057); Delayed Charge Time (2586)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2019

Event Type  Injury  

Event Description

It was reported that there was premature battery depletion (pbd) and delayed charge time, on this cardiac resynchronization therapy defibrillator (crt-d).Data analysis confirmed that there were two long charges that set the elective replacement indicator.The device has also recorded 929 magnet applications.Magnet application can also cause an increase in battery consumption and may be the cause of the reported 105uw power consumption.The patient has hyperbaric oxygen therapy and radiation therapy.The crt-d was removed and replaced.No additional adverse patient effects were reported.This product has been returned.This report will be updated upon analysis completion.

Manufacturer Narrative

This device was thoroughly inspected and analyzed.Review of device memory confirmed that the device had reached elective replacement indicator (eri) status due to long charge times, during a period of magnet application for two and a half hours.A manual capacitor reform was performed, and the charge time was 9.4 seconds.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.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.

Event Description

Additional information indicated that device evaluation was completed.

• 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: 9549966
• MDR Text Key: 173714686
• Report Number: 2124215-2019-25473
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2019
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 172191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR