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

Model Number	D021
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator and non boston scientific right ventricular (rv) lead exhibited fluctuating pace impedance measurements including greater than 3,000 ohms.There was occasional noise on the shock channel however, no oversensing observed.Shock impedance measurements were noted to be stable.Additional information was received that the isometrics and impedances were checked in the clinic and there was no noise or out of range measurements re-produced.The healthcare provider was going to continue to monitor the patient.The device 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.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction 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.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator and non boston scientific right ventricular (rv) lead exhibited fluctuating pace impedance measurements including greater than 3,000 ohms.There was occasional noise on the shock channel however, no oversensing observed.Shock impedance measurements were noted to be stable.Additional information was received that the isometrics and impedances were checked in the clinic and there was no noise or out of range measurements re-produced.The healthcare provider was going to continue to monitor the patient.The device remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11661417
• Report Number: 2124215-2021-05105
• Device Sequence Number: 19614893
• Product Code: LWS
• UDI-Device Identifier: 00802526533884
• UDI-Public: 00802526533884
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 09/06/2020
• Device Model Number: D021
• Device Catalogue Number: D021
• Device Lot Number: 109128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR