MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D023
Medical Device Problem Codes	Over-Sensing (1438); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device exhibited a stored signal artifact monitor (sam) episode due to oversensing signals on the right atrial (ra) lead.As a result, the respiratory rate trend (rrt) sensors monitoring vector was automatically switched to the right ventricular (rv) lead.In addition, the ra lead is exhibiting intermittent sudden increases in pace impedance measurements, with measurements as high as 1306 ohms, which is still within normal specification limits.The ra lead is not a boston scientific product.Boston scientific technical services (ts) discussed with the healthcare provider (hcp) the rrt sensor, transthoracic impedance signals and rrt oversensing.Ts indicated rrt oversensing can sometimes develop with systems containing a device and leads from different manufacturers.Ts explained that the rrt monitoring vector has switched and noted rrt oversensing should not be a problem with the rv lead, as it is also a boston scientific product.Ts noted that they reviewed the most recent atrial tachy response (atr) episodes, and they were free of noise.Ts provided guidance to consider monitoring for now.Ts also stated that the ra lead upper limit is 2000 ohms so an alert may occur in the future if the sudden increases in ra pace impedance measurements persist.The products remain in-service.There were no adverse patient effects.
Additional 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 rate trend (rrt) 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.

• Brand Name: DYNAGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 15988081
• Report Number: 2124215-2022-52941
• Device Sequence Number: 5995927
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: 00802526533921
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/18/2017
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 245277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female