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

Model Number	D011
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had migrated approximately 5cm below the incision site.It was noted that the patient had a previous pocket revision, however it was unclear when the revision occurred or whether the revision was performed on this particular device.Medical records indicate this device was originally implanted subpectoral.In addition, there was oversensed noise with pacing inhibition and decreasing impedance measurements observed on this implantable cardioverter defibrillator (icd), implanted with another manufacturer's right ventricular (rv) lead.There was no indication of greater than two seconds.All lead measurements were within normal limits.An x-ray was taken which showed a loop in the rv lead body that appears to be between the shocking coils, and insulation breach was suspected as well.Subsequently, this icd system was explanted and replaced.It was noted that the patient was bradycardic and upgraded to a dual chamber device.No additional adverse patient effects were reported.This icd was returned for analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had migrated approximately 5cm below the incision site.It was noted that the patient had a previous pocket revision, however it was unclear when the revision occurred or whether the revision was performed on this particular device.Medical records indicate this device was originally implanted sub-pectorally.In addition, there was over-sensed noise with pacing inhibition and decreasing impedance measurements observed on this implantable cardioverter defibrillator (icd), implanted with another manufacturer's right ventricular (rv) lead.There was no indication of greater than two seconds.All lead measurements were within normal limits.An x-ray was taken which showed a loop in the rv lead body that appears to be between the shocking coils, and insulation breach was suspected as well.Subsequently, this icd system was explanted and replaced.It was noted that the patient was bradycardic and upgraded to a dual chamber device.No additional adverse patient effects were reported.This icd was returned for analysis.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.-- the returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Pin gage testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.The associated investigation also determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection.

• 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: 16605043
• Report Number: 2124215-2023-13833
• Device Sequence Number: 14989794
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 07/29/2016
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 437593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male