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

Model Number	D023
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) stated that their remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, however the issue has not been resolved.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.
Additional Manufacturer Narrative
Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field d6b: explant date h1: type of reportable event h6: impact codes.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) stated that their remote communicator displayed a red call doctor icon.Subsequently, troubleshooting was performed, and the communicator was power cycled, however the issue has not been resolved.The patient was referred to contact their clinic regarding the red call doctor icon.At this time, this device remains in service and there were no adverse patient effects reported.Additional information was received detailing that the device was explanted and replaced.

• Brand Name: DYNAGEN MINI ICD DR
• Common Device Name: IMPLANTABLE 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: 17402292
• Report Number: 2124215-2023-39712
• Device Sequence Number: 7493812
• 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: 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
• Report Date (Section B): 09/12/2023

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: 05/27/2017
• Device Model Number: D023
• Device Catalogue Number: D023
• Device Lot Number: 245379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Male