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); Battery Problem (2885)

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

Event Date 07/25/2023

Event Type  malfunction  

Event Description

It was reported that there were concerns regarding the cardiac resynchronization therapy defibrillator (crt-d) charge time of 14.3 seconds with premature battery depletion.The local boston scientific representative wants to know if this is normal for this type of older model.Data analysis was requested, and boston scientific technical services indicated that the latitude data is too old for premature battery depletion (pbd) analysis, please have the patient perform a patient-initiated interrogation (pii) or provide an in-clinic follow-up save to disk for review.No new data has been provided for review.No adverse patient effects were reported.This device remains in-service.

Event Description

It was reported that there were concerns regarding the cardiac resynchronization therapy defibrillator (crt-d) charge time of 14.3 seconds with suspected premature battery depletion.The local boston scientific representative wants to know if this is normal for this type of older model.Data analysis was requested, and boston scientific technical services indicated that the latitude data is too old for premature battery depletion (pbd) analysis, please have the patient perform a patient-initiated interrogation (pii) or provide an in-clinic follow-up save to disk for review.Multiple requests for new data to be provided for review but none had been made available.No adverse patient effects were reported.This device remains in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• 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: 17538006
• MDR Text Key: 321270335
• Report Number: 2124215-2023-43227
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 103489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/13/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1