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

Model Number	D021
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was returned from our final pack area for analysis as the product had not passed all required testing.This icd was not implanted, and no patient involvement was 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
• 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: 13677557
• Report Number: 2124215-2022-00687
• Device Sequence Number: 12129090
• Product Code: LWS
• UDI-Device Identifier: 00802526533884
• UDI-Public: 00802526533884
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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: Other
• Device Expiration Date: 08/24/2020
• Device Model Number: D021
• Device Catalogue Number: D021
• Device Lot Number: 109049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 03/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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 Sex: Unknown