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

Model Number G247

Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Low impedance (2285); High Capture Threshold (3266)

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

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a left ventricular (lv) lead has been showing an abnormal power consumption.Also, the lv lead showed low, out of range pacing values and thresholds significantly elevated.The physician was concerned about lv lead having moved or a possible dislodgement or pull back.The lv lead was reprogrammed in clinic to a different vector and the output decreased.Additionally, there are also presenting electrogram (egm) deflections on the lv channel seen but not sensed during atrial paced events.It appears that an lv lead revision is being planned but it was recommended to explant the crt-d as well.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a left ventricular (lv) lead has been showing an abnormal power consumption.Also, the lv lead showed low, out of range pacing values and thresholds significantly elevated.The physician was concerned about lv lead having moved or a possible dislodgement or pull back.The lv lead was reprogrammed in clinic to a different vector and the output decreased.Additionally, there are also presenting electrogram (egm) deflections on the lv channel seen but not sensed during atrial paced events.It appears that an lv lead revision is being planned but it was recommended to explant the crt-d as well.At this time both the crt-d and the lv lead have been explanted at a surgical intervention.The crt-d had an additional allegation of premature battery depletion and along with the lv, they have been returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a left ventricular (lv) lead has been showing an abnormal power consumption.Also, the lv lead showed low, out of range pacing values and thresholds significantly elevated.The physician was concerned about lv lead having moved or a possible dislodgement or pull back.The lv lead was reprogrammed in clinic to a different vector and the output decreased.Additionally, there are also presenting electrogram (egm) deflections on the lv channel seen but not sensed during atrial paced events.It appears that an lv lead revision is being planned but it was recommended to explant the crt-d as well.At this time both the crt-d and the lv lead have been explanted at a surgical intervention.The crt-d and the lv have been returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this system with a cardiac resynchronization therapy defibrillator (crt-d) and a left ventricular (lv) lead has been showing an abnormal power consumption.Also, the lv lead showed low, out of range pacing values and thresholds significantly elevated.The physician was concerned about lv lead having moved or a possible dislodgement or pull back.The lv lead was reprogrammed in clinic to a different vector and the output decreased.Additionally, there are also presenting electrogram (egm) deflections on the lv channel seen but not sensed during atrial paced events.It appears that an lv lead revision is being planned but it was recommended to explant the crt-d as well.At this time both the crt-d and the lv lead have been explanted at a surgical intervention.The crt-d had an additional allegation of premature battery depletion and along with the lv, they have been returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the product was performed.Review of device memory confirmed the presence of a higher than normal current drain condition.Electrical testing and analysis were then conducted, which isolated the high current to an anomaly in an oxide layer within a custom integrated circuit component.This anomaly caused a high current drain, which over time resulted in the reported clinical observations.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17727000
• MDR Text Key: 323154576
• Report Number: 2124215-2023-49557
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2023

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: 300052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 09/11/2023; 11/16/2023
• Supplement Dates FDA Received: 10/02/2023; 10/08/2023; 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female