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

Model Number	D010
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there were concerns regarding alleged premature battery with this implantable cardioverter defibrillator (icd).At the last follow-up, this device showed one year estimated battery longevity remaining.At the most recent follow-up, this device triggered end of life and interrogation was not possible.Subsequently, this device was explanted and replaced immediately.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that there were concerns regarding alleged premature battery with this implantable cardioverter defibrillator (icd).At the last follow-up, this device showed one year estimated battery longevity remaining.At the most recent follow-up, this device triggered end of life and interrogation was not possible.Subsequently, this device was explanted and replaced immediately.No additional adverse patient effects were reported.This device will not return for analysis, it was discarded.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• Brand Name: INOGEN 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16120795
• Report Number: 2124215-2023-00562
• Device Sequence Number: 6382826
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 06/26/2016
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 102986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male