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

Model Number G148

Device Problems Battery Problem (2885); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) reached elective replacement indicator (eri) and exhibited beeping tones.Disk analysis indicated that the device set eri due to the high power consumption that was occurring at the time.The device is likely experiencing some time of hardware issue and the power consumption moving forward could change unpredictably.Additional information from the medical records indicated that the device was surgically explanted and was replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.Upon receipt at our post market quality assurance laboratory, an evaluation of this cardiac resynchronization therapy defibrillator (crt-d) was performed.Analysis showed that the device triggered replacement indicator while implanted.The daily battery voltage measurements displayed a pattern of steady and rapid discharge.The pg diagnostic data spreadsheet shows a cell depletion pattern that is similar to other devices that have high power consumption.Before it was cut open, the device passed the therapy verification portions of automated electrical testing.Visual inspection of the already disassembled device noted a dremel tool cut some of the traces on the hybrid near the mmic.The mmic has gouges in it created by some kind of tool and the mmic was also cracked.Laboratory analysis confirmed reported allegation.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) reached elective replacement indicator (eri) and exhibited beeping tones.Disk analysis indicated that the device set eri due to the high-power consumption that was occurring at the time.The device is likely experiencing some time of hardware issue and the power consumption moving forward could change unpredictably.Additional information from the medical records indicated that the device was surgically explanted.No additional adverse patient effects were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12701826
• MDR Text Key: 278523414
• Report Number: 2124215-2021-32362
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/05/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 152873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female