MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	D012
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there is a concern for a suspected inappropriate anti-tachycardia pacing (atp) and shock therapy from this implantable cardioverter defibrillator (icd).Boston scientific technical services (ts) performed an analysis in which it was determined that there may be inappropriate therapy for a supraventricular tachycardia.It was also noted that therapy exhaustion occurred; ts recommended programming enhancements.The device remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that there is a concern for a suspected inappropriate anti-tachycardia pacing (atp) and shock therapy from this implantable cardioverter defibrillator (icd).Boston scientific technical services (ts) performed an analysis in which it was determined that there may be inappropriate therapy for a supraventricular tachycardia.It was also noted that therapy exhaustion occurred; ts recommended programming enhancements.The device remains in service.No additional adverse patient effects were reported.Additional information was received indicating that this device was explanted due to normal battery depletion.This device was returned.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, 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.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 17840388
• Report Number: 2124215-2023-53603
• Device Sequence Number: 6759172
• Product Code: LWS
• UDI-Device Identifier: 00802526533822
• UDI-Public: 00802526533822
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 08/22/2017
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 107123
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2015
• 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: Other
• Patient Age: 77 YR
• Patient Sex: Male