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

Model Number G150

Device Problems High impedance (1291); Over-Sensing (1438); Noise, Audible (3273)

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

Event Date 09/03/2022

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) produced beeping tones.Upon interrogation, there was an alert for right atrial (ra) lead impedance greater than 3000 ohms.Technical services (ts) analyzed device data and recommended that the patient come into the clinic for further testing and isometrics.It was noted that the tones were expected for this alert.The ra lead is a non-boston scientific product.It was also found that that there was a stored signal artifact monitoring (sam) episode where there was a vector switch due to respiratory rate trend (rrt) noise and oversensing.No adverse patient effects were reported.Currently, this crt-d system remains in service.

Event Description

It was reported that that this cardiac resynchronization therapy defibrillator (crt-d) produced beeping tones.Upon interrogation, there was an alert for right atrial (ra) lead impedance greater than 3000 ohms.Technical services (ts) analyzed device data and recommended that the patient come into the clinic for further testing and isometrics.It was noted that the tones were expected for this alert.The ra lead is a non-boston scientific product.It was also found that that there was a stored signal artifact monitoring (sam) episode where there was a vector switch due to respiratory rate trend (rrt) noise and oversensing.No adverse patient effects were reported.Currently, this crt-d system remains in service.

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 respiratory sensor that is related to intermittent increases in impedance measurements.Additionally, engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field 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 respiratory sensor that is related to intermittent increases in impedance measurements.Additionally, engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.

Event Description

It was reported that that this cardiac resynchronization therapy defibrillator (crt-d) produced beeping tones.Upon interrogation, there was an alert for right atrial (ra) lead impedance greater than 3000 ohms.Technical services (ts) analyzed device data and recommended that the patient come into the clinic for further testing and isometrics.It was noted that the tones were expected for this alert.The ra lead is a non-boston scientific product.It was also found that that there was a stored signal artifact monitoring (sam) episode where there was a vector switch due to respiratory rate trend (rrt) noise and oversensing.No adverse patient effects were reported.Currently, this crt-d system remains in service.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 respiratory sensor that is related to intermittent increases in impedance measurements.Additionally, engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.According to additional information, the right ventricular (rv) lead of this crt-d system exhibited high out-of-range shock impedance measurements.Device data analysis noted that the shock impedance measurement was greater than 260 ohms.The programmed shock vector was rv coil to right atrial ra coil and can, and shock impedance measurements were previously stable in the upper 30 ohms range throughout the last year.However, there was more variability within the 50 ohms range within the last week.Further evaluation in-clinic was recommended, and ts discussed troubleshooting options.The rv lead was not manufactured by boston scientific.This crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN 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: 15941218
• MDR Text Key: 307912225
• Report Number: 2124215-2022-51241
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: 00802526534614
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2021
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 494487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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 Age: 60 YR
• Patient Sex: Male