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

Model Number G148

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Noise, Audible (3273)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beep tones and a request was made to have data from this device analyzed.Data analysis showed an alert for an out-of-range shock impedance measurement that could have caused the device to beep.It was also found that right ventricular (rv) and left ventricular (lv) impedance measurements from that same day were not successfully taken due to noise, and technical services (ts) noted it may be possible there was some electromagnetic interference (emi) impeding the correct measurements of the impedances.Ts recommended asking the patient what they were doing on the date of the measurement that could have exposed the patient to emi as there is no indication of a lead impairment situation.No adverse patient effects were reported.This crt-d system remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beep tones and a request was made to have data from this device analyzed.Data analysis showed an alert for an out-of-range shock impedance measurement that could have caused the device to beep.It was also found that right ventricular (rv) and left ventricular (lv) impedance measurements from that same day were not successfully taken due to noise, and technical services (ts) noted it may be possible there was some electromagnetic interference (emi) impeding the correct measurements of the impedances.Ts recommended asking the patient what they were doing on the date of the measurement that could have exposed the patient to emi as there is no indication of a lead impairment situation.No adverse patient effects were reported.This crt-d system remains in service.Additional information received indicates this patient was seen in follow-up, and the health care professional (hcp) was unable to reproduce any noise.Therefore, a manual shock was performed.The resulting impedance was within normal limits.The nursing team at the facility will follow-up with this patient more frequently.No additional adverse patient effects were reported.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) emitted beep tones and a request was made to have data from this device analyzed.Data analysis showed an alert for an out-of-range shock impedance measurement that could have caused the device to beep.It was also found that right ventricular (rv) and left ventricular (lv) impedance measurements from that same day were not successfully taken due to noise, and technical services (ts) noted it may be possible there was some electromagnetic interference (emi) impeding the correct measurements of the impedances.Ts recommended asking the patient what they were doing on the date of the measurement that could have exposed the patient to emi as there is no indication of a lead impairment situation.No adverse patient effects were reported.This crt-d system remains in service.Additional information received indicates this patient was seen in follow-up, and the health care professional (hcp) was unable to reproduce any noise.Therefore, a manual shock was performed.The resulting impedance was within normal limits.The nursing team at the facility will follow-up with this patient more frequently.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: 15565726
• MDR Text Key: 305370234
• Report Number: 2124215-2022-40341
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/04/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 134788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• 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): Required Intervention