MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D021
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had an alert indicating that there was an out of range pacing impedance value on the right ventricular (rv) lead channel.Technical services (ts) reviewed the reports and advised monitoring the issue as the impedance values were slightly below the nominal upper limit.Ts noted there were no noisy signals in the logbook or in the presenting.The device remains in use.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had an alert indicating that there was an out of range pacing impedance value on the right ventricular (rv) lead channel.Technical services (ts) reviewed the reports and advised monitoring the issue as the impedance values were slightly below the nominal upper limit.Ts noted there were no noisy signals in the logbook or in the presenting.The device remains in use.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.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

• Brand Name: DYNAGEN MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER 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 55112-5798 ; 6515826168
• MDR Report Key: 19067189
• Report Number: 2124215-2024-21265
• Device Sequence Number: 6677427
• Product Code: LWS
• UDI-Device Identifier: 00802526533884
• UDI-Public: 00802526533884
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 05/03/2020
• Device Model Number: D021
• Device Catalogue Number: D021
• Device Lot Number: 108419
• 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: 03/23/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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
• Patient Age: 65 YR
• Patient Sex: Female