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

Model Number	D023
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)
Health Effect - Clinical Codes	Unspecified Infection (1930); Electric Shock (2554)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) has reached explant indicator.Additionally, it was noted that the patient has an infection however, the health care professional (hcp) does not think it is related to the device.It was noted that the patient received shock therapy however, the total number of shocks were unknown, and the cause is unknown since the review of episodes are not an option.The hcp was inquiring about device settings.Technical services discussed how tachy therapy zone was at 165 and whereas before tachy therapy did not start until 200.There were several stored episodes in which the tachy zone was between 150-200.At this time, the device and non-boston scientific right atrial (ra) and right ventricular (rv) lead remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) has reached explant indicator.Additionally, it was noted that the patient has an infection however, the health care professional (hcp) does not think it is related to the device.It was noted that the patient received shock therapy however, the total number of shocks were unknown, and the cause is unknown since the review of episodes are not an option.The hcp was inquiring about device settings.Technical services discussed how tachy therapy zone was at 165 and whereas before tachy therapy did not start until 200.There were several stored episodes in which the tachy zone was between 150-200.At this time, the device and non-boston scientific right atrial (ra) and right ventricular (rv) lead remains in service.No additional adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported this implantable cardioverter defibrillator (icd) was explanted due to infection.No additional adverse patient effects were reported.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18300530
• Report Number: 2124215-2023-70001
• Device Sequence Number: 3227436
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: 00802526533921
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 12/14/2023

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: 04/05/2018
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 246961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male