MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G148

Device Problem Premature Discharge of Battery (1057)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.The distributor asked boston scientific technical services (ts) if the device should be explanted or if it can be monitored for now.Ts explained that device data is not available at this time to perform a battery analysis and recommended setting up and linking a remote communicator to the device to monitor the patient and to gather data for the analysis.No adverse patient effects were reported.The device remains in service.The distributor has tried multiple times to contact the physician, but no new information regarding next steps for this device has been received.No adverse patient effects were reported.Evidence suggests that at this time, this device remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.The distributor asked boston scientific technical services (ts) if the device should be explanted or if it can be monitored for now.Ts explained that device data is not available at this time to perform a battery analysis and recommended setting up and linking a remote communicator to the device to monitor the patient and to gather data for the analysis.No adverse patient effects were reported.The device remains in service.The distributor has tried multiple times to contact the physician, but no new information regarding next steps for this device has been received.No adverse patient effects were reported.Evidence suggests that at this time, this device remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 which is indicative of battery voltage too low for the projected remaining capacity.The distributor asked boston scientific technical services (ts) if the device should be explanted or if it can be monitored for now.Ts explained that device data is not available at this time to perform a battery analysis and recommended setting up and linking a remote communicator to the device to monitor the patient and to gather data for the analysis.No adverse patient effects were reported.The device remains in service.The distributor has tried multiple times to contact the physician, but no new information regarding next steps for this device has been received.No adverse patient effects were reported.Evidence suggests that at this time, this device remains in service.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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: 18776749
• MDR Text Key: 336197036
• Report Number: 2124215-2024-11160
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/09/2024
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 279785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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 Age: 74 YR