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

Model Number	D023
Medical Device Problem Codes	High impedance (1291); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the communicator for this implantable cardioverter defibrillator (icd) was showing a red call doctor icon, three yellow collecting waves, two yellow sending waves and was not able to connect.A boston scientific company representative had referred the patient to the clinic.The communicator issue was not resolved.A new cellular adapter was sent.The communicator remains in service and the icd has been explanted due to normal battery depletion.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the communicator for this implantable cardioverter defibrillator (icd) was showing a red call doctor icon, three yellow collecting waves, two yellow sending waves and was not able to connect.A boston scientific company representative had referred the patient to the clinic.The communicator issue was not resolved.A new cellular adapter was sent.The communicator remains in service and the icd has been explanted due to normal battery depletion.Additional information was received from the field representative mentioning that there was a yellow alert due to high, out-of-range right atrial (ra) lead pacing impedances.Both ra and icd remain in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the communicator for this implantable cardioverter defibrillator (icd) was showing a red call doctor icon, three yellow collecting waves, two yellow sending waves and was not able to connect.A boston scientific company representative had referred the patient to the clinic.The communicator issue was not resolved.A new cellular adapter was sent.The communicator remains in service and the icd has been explanted due to normal battery depletion.Additional information was received from the field representative mentioning that there was a yellow alert due to high, out-of-range right atrial (ra) lead pacing impedances.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DYNAGEN MINI ICD DR
• 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 ; 6515826168
• MDR Report Key: 18362197
• Report Number: 2124215-2023-72477
• Device Sequence Number: 12766064
• Product Code: LWS
• UDI-Device Identifier: 00802526533921
• UDI-Public: 00802526533921
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2024

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: 11/08/2018
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 247991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/11/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 12/21/2023; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2016
• 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
• Patient Age: 61 YR
• Patient Sex: Male