MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD DR; IMPLANTABLE DEVICE

Model Number	D023
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) called for review of device data for this patient with an implantable cardioverter defibrillator (icd).The hcp suspects the non-boston scientific right atrial (ra) lead is fractured.Technical services reviewed the device data and found ra impedances have been variable to high out-of-range.Measuring greater than 3,000 ohms.Additionally, there was observations of noise that was being oversensed by the respiratory rate trend (rrt) sensor.Technical services discussed possible causes and recommended to interrogate using the programmer.At this time, the icd system remains in service.No adverse patient effects were reported.
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 minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.
Event or Problem Description
It was reported that the health care professional (hcp) called for review of device data for this patient with an implantable cardioverter defibrillator (icd).The hcp suspects the non-boston scientific right atrial (ra) lead is fractured.Technical services reviewed the device data and found ra impedances have been variable to high out-of-range.Measuring greater than 3,000 ohms.Additionally, there was observations of noise that was being oversensed by the respiratory rate trend (rrt) sensor.Technical services discussed possible causes and recommended to interrogate using the programmer.At this time, the icd system remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the health care professional (hcp) called for review of device data for this patient with an implantable cardioverter defibrillator (icd).The hcp suspects the non-boston scientific right atrial (ra) lead is fractured.Technical services reviewed the device data and found ra impedances have been variable to high out-of-range.Measuring greater than 3,000 ohms.Additionally, there was observations of noise that was being oversensed by the respiratory rate trend (rrt) sensor.Technical services discussed possible causes and recommended to interrogate using the programmer.At this time, the icd system remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that this pacemaker was explanted and replaced successfully.The non-boston scientific right atrial (ra) lead remains in service.No additional adverse patient effects were reported.
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 minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.

• Brand Name: DYNAGEN MINI ICD DR
• Common Device Name: IMPLANTABLE DEVICE
• 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: 16185588
• Report Number: 2124215-2023-01669
• Device Sequence Number: 2633495
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: 00802526533921
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2018
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 247094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/31/2023; 10/10/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/01/2023; 10/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female