MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD DR; IMPLANTABLE DEVICE

Model Number	D013
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Telemetry Discrepancy (1629); Noise, Audible (3273)
Health Effect - Clinical Codes	Electric Shock (2554); No Code Available (3191)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated during a routine follow up.This device was also reported to have emitted beeping tones.A changeout procedure was scheduled.Prior to change out, the patient reported receiving nine shocks due to atrial fibrillation (af).This device was then explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Patient code 3191 was applied to capture the reportable event of surgery.The product has been received for analysis.This report will be updated upon completion of analysis.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.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.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated during a routine follow up.This device was also reported to have emitted beeping tones.A changeout procedure was scheduled.Prior to change out, the patient reported receiving nine shocks due to atrial fibrillation (af).This device was then explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10636807
• Report Number: 2124215-2020-19294
• Device Sequence Number: 2604477
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 06/12/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 102156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR