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

Model Number G151

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2020

Event Type  Injury  

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 the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the clinician requested boston scientific technical services (ts) review of an atrial tachy response (atr) episode for possible electromagnetic interference (emi) and oversensing noise on the right atrial (ra) channel.Upon review ts noted the noise could be consistent with minute ventilation sensor oversensing.There were no known sources of emi.Ts discussed the option of programming the respiratory rate trend (rrt) feature off and checking the leads.The field representative noted that the rrt feature was programmed off in the cardiac resynchronization therapy defibrillator (crt-d) two days later.The crt-d and ra lead remain in service and no adverse patient effects were reported.

Event Description

It was reported that the clinician requested boston scientific technical services (ts) review of an atrial tachy response (atr) episode for possible electromagnetic interference (emi) and oversensing noise on the right atrial (ra) channel.Upon review ts noted the noise could be consistent with minute ventilation sensor oversensing.There were no known sources of emi.Ts discussed the option of programming the respiratory rate trend (rrt) feature off and checking the leads.The field representative noted that the rrt feature was programmed off in the cardiac resynchronization therapy defibrillator (crt-d) two days later.The crt-d and ra lead remain in service and no adverse patient effects were reported.Additional information was received and this right atrial (ra) lead was fractured.High out of range impedance measurements above 3000 ohms have been exhibited, oversensed noise that was not lined up with p waves.This ra lead remains in service.No adverse patient effects were reported.

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 the description for more information regarding the specific circumstances of this event.

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 the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the clinician requested boston scientific technical services (ts) review of an atrial tachy response (atr) episode for possible electromagnetic interference (emi) and oversensing noise on the right atrial (ra) channel.Upon review ts noted the noise could be consistent with minute ventilation sensor oversensing.There were no known sources of emi.Ts discussed the option of programming the respiratory rate trend (rrt) feature off and checking the leads.The field representative noted that the rrt feature was programmed off in the cardiac resynchronization therapy defibrillator (crt-d) two days later.The crt-d and ra lead remain in service and no adverse patient effects were reported.Additional information was received and this right atrial (ra) lead was fractured.High out of range impedance measurements above 3000 ohms have been exhibited, oversensed noise that was not lined up with p waves.This ra lead remains in service.No adverse patient effects were reported.Additional information was received and the ra lead was explanted due to high impedance, no sensing, and loss of capture.The ra lead was replaced and the crt-d was explanted due to therapy upgrade.No additional adverse patient effects were reported.

Event Description

It was reported that the clinician requested boston scientific technical services (ts) review of an atrial tachy response (atr) episode for possible electromagnetic interference (emi) and oversensing noise on the right atrial (ra) channel.Upon review ts noted the noise could be consistent with minute ventilation sensor oversensing.There were no known sources of emi.Ts discussed the option of programming the respiratory rate trend (rrt) feature off and checking the leads.The field representative noted that the rrt feature was programmed off in the cardiac resynchronization therapy defibrillator (crt-d) two days later.The crt-d and ra lead remain in service and no adverse patient effects were reported.Additional information was received and this right atrial (ra) lead was fractured.High out of range impedance measurements above 3000 ohms have been exhibited, oversensed noise that was not lined up with p waves.This ra lead remains in service.No adverse patient effects were reported.Additional information was received and the ra lead was explanted due to high impedance, no sensing, and loss of capture.The ra lead was replaced and the crt-d was explanted due to therapy upgrade.No additional adverse patient effects were reported.

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 the description for more information regarding the specific circumstances of this event.

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 the description for more information regarding the specific circumstances of this event.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.This device was included in the minute ventilation sensor signal oversensing advisory population.

Event Description

It was reported that the clinician requested boston scientific technical services (ts) review of an atrial tachy response (atr) episode for possible electromagnetic interference (emi) and oversensing noise on the right atrial (ra) channel.Upon review ts noted the noise could be consistent with minute ventilation sensor oversensing.There were no known sources of emi.Ts discussed the option of programming the respiratory rate trend (rrt) feature off and checking the leads.The field representative noted that the rrt feature was programmed off in the cardiac resynchronization therapy defibrillator (crt-d) two days later.The crt-d and ra lead remain in service and no adverse patient effects were reported.Additional information was received and this right atrial (ra) lead was fractured.High out of range impedance measurements above 3000 ohms have been exhibited, oversensed noise that was not lined up with p waves.This ra lead remains in service.No adverse patient effects were reported.Additional information was received and the ra lead was explanted due to high impedance, no sensing, and loss of capture.The ra lead was replaced and the crt-d was explanted due to therapy upgrade.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN 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: 11211826
• MDR Text Key: 228165312
• Report Number: 2124215-2020-28766
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2023

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 Expiration Date: 08/27/2022
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 142042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 11/03/2022; 12/15/2022; 02/03/2023; 06/28/2023
• Supplement Dates FDA Received: 11/23/2022; 01/04/2023; 02/06/2023; 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female