MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D010
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements on the right ventricular (rv) lead.Upon review, it was noted that the shock measurements have been high for the past years.Also, was observed that this icd reached a battery status of elective replacement indicator (eri).A save to disk was sent in for engineering analysis and it was confirmed that this icd is depleting normally and the eri was declared due to high voltages charges in excess of 15 seconds consumption.This is a secondary mechanism for setting eri and is not tracked by the longevity calculation algorithm.Engineering analysis confirms 90-day eri to eol (end of life) in case more time is needed.At this time, the product remains in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was added to the following fields to capture the revision procedure of the device: b1: adverse event/product problem.B2: outcome attributed to adverse event.B5: describe the event or problem field.D6b: explant date.H1: type of reportable event.H6: impact codes.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements on the right ventricular (rv) lead.Upon review, it was noted that the shock measurements have been high for the past years.Also, was observed that this icd reached a battery status of elective replacement indicator (eri).A save to disk was sent in for engineering analysis and it was confirmed that this icd is depleting normally and the eri was declared due to high voltages charges in excess of 15 seconds consumption.This is a secondary mechanism for setting eri and is not tracked by the longevity calculation algorithm.Engineering analysis confirms 90-day eri to eol (end of life) in case more time is needed.Subsequently, a revision procedure was performed and the rv lead was surgically abandoned, while the icd was explanted.Both products were successfully replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurements on the right ventricular (rv) lead.Upon review, it was noted that the shock measurements have been high for the past years.Also, was observed that this icd reached a battery status of elective replacement indicator (eri).A save to disk was sent in for engineering analysis and it was confirmed that this icd is depleting normally and the eri was declared due to high voltages charges in excess of 15 seconds consumption.This is a secondary mechanism for setting eri and is not tracked by the longevity calculation algorithm.Engineering analysis confirms 90-day eri to eol (end of life) in case more time is needed.Subsequently, a revision procedure was performed and the rv lead was surgically abandoned, while the icd was explanted.Both products were successfully replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, analysis of the returned device found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.The device was subjected to and passed all automated testing.Laboratory analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields to capture the revision procedure of the device: b1: adverse event/product problem.B2: outcome attributed to adverse event.B5: describe the event or problem field.D6b: explant date.H1: type of reportable event.H6: impact codes.

• Brand Name: INOGEN MINI ICD VR
• 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; 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: 18023281
• Report Number: 2124215-2023-60048
• Device Sequence Number: 7759201
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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: 10/19/2017
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 209400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 01/23/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 11/02/2023; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2015
• 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 Age: 58 YR
• Patient Sex: Female