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

Model Number G247

Device Problems High impedance (1291); Failure to Read Input Signal (1581)

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

Event Date 10/07/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range impedance on the right ventricular (rv) channel.Additionally, the left ventricular (lv) channel had amplitudes out of range.When the patient was seen in clinic, it was noted that the rv channel also had loss of capture (loc).It was noted that the lv channel was fine.An echocardiogram showed that everything appeared as expected.The physician plans to monitor the patient for now but noted other troubleshooting actions may be done in the future.The device remains in use.No adverse patient effects were reported.

Manufacturer Narrative

This report contains additional information in section b1 adverse event/product problem, b5 adverse event/product problem, h6 patient codes and h6 impact codes.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range impedance on the right ventricular (rv) channel.Additionally, the left ventricular (lv) channel had amplitudes out of range.When the patient was seen in clinic, it was noted that the rv channel also had loss of capture (loc).It was noted that the lv channel was fine.An echocardiogram showed that everything appeared as expected.The physician plans to monitor the patient for now but noted other troubleshooting actions may be done in the future.The device remains in use.No adverse patient effects were reported.Additional information received indicated that defibrillation threshold (dft) test was successfully performed, and the plan is to continue monitoring.No additional patient adverse effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited high out of range impedance on the right ventricular (rv) channel.Additionally, the left ventricular (lv) channel had amplitudes out of range.When the patient was seen in clinic, it was noted that the rv channel also had loss of capture (loc).It was noted that the lv channel was fine.An echocardiogram showed that everything appeared as expected.The physician plans to monitor the patient for now but noted other troubleshooting actions may be done in the future.The device remains in use.No adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 17950215
• MDR Text Key: 325930521
• Report Number: 2124215-2023-57565
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 313945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 11/08/2023; 11/17/2023
• Supplement Dates FDA Received: 11/09/2023; 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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; Other
• Patient Age: 83 YR
• Patient Sex: Male