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

Model Number G447

Device Problems Over-Sensing (1438); Inaccurate Synchronization (1609); Impedance Problem (2950); Material Integrity Problem (2978)

Patient Problem Arrhythmia (1721)

Event Date 06/30/2023

Event Type  Injury  

Event Description

It was reported that this patient was admitted to the hospital due to an acute right atrial (ra) lead dislodgement and appropriate shocks for ventricular tachycardia (vt).It was determined that the vt was initiated due to the lead being impacted on the tricuspid valve.Additionally, a signal artifact monitoring (sam) event was noted due to over-sensed non-physiological artifacts.The physician was concerned about a potential device header issue.Boston scientific technical services (ts) was contacted for a data review.Ts discussed that there was an increase in the left ventricular (lv) lead impedance measurements which could be the result of micro-dislodgement.Fluctuations in the ra lead impedance were also noted.However, at this time, ts did not see evidence of a potential header issue.It was stated that a lead revision procedure was scheduled, but has not yet occurred.At this time, the system remains implanted and in-service and the patient was stable.It is unknown if the ra and lv leads are boston scientific products.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see b5 for more information regarding the specific circumstances of this event.

Event Description

It was reported that this patient was admitted to the hospital due to an acute right atrial (ra) lead dislodgement and appropriate shocks for ventricular tachycardia (vt).It was determined that the vt was initiated due to the lead being impacted on the tricuspid valve.Additionally, a signal artifact monitoring (sam) event was noted due to over-sensed non-physiological artifacts.The physician was concerned about a potential device header issue.Boston scientific technical services (ts) was contacted for a data review.Ts discussed that there was an increase in the left ventricular (lv) lead impedance measurements which could be the result of micro-dislodgement.Fluctuations in the ra lead impedance were also noted.However, at this time, ts did not see evidence of a potential header issue.It was stated that a lead revision procedure was scheduled, but has not yet occurred.At this time, the system remains implanted and in-service and the patient was stable.It is unknown if the ra and lv leads are boston scientific products.

Event Description

It was reported that this patient was admitted to the hospital due to an acute right atrial (ra) lead dislodgement and appropriate shocks for ventricular tachycardia (vt).It was determined that the vt was initiated due to the lead being impacted on the tricuspid valve.Additionally, a signal artifact monitoring (sam) event was noted due to over-sensed non-physiological artifacts.The physician was concerned about a potential device header issue.Boston scientific technical services (ts) was contacted for a data review.Ts discussed that there was an increase in the left ventricular (lv) lead impedance measurements which could be the result of micro-dislodgement.Fluctuations in the ra lead impedance were also noted.However, at this time, ts did not see evidence of a potential header issue.It was stated that a lead revision procedure was scheduled, but has not yet occurred.Information was requested regarding the procedure, as well as the identifying lead information, but a response was not received.At this time, the system remains implanted and in-service and the patient was stable.It is unknown if the ra and lv leads are boston scientific products.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see b5 for more information regarding the specific circumstances of this event.

• Brand Name: RESONATE 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: 17443726
• MDR Text Key: 320234213
• Report Number: 2124215-2023-41035
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 295587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 58 YR