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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported during a routine follow up appointment that this implantable cardioverter defibrillator (icd) device exhibited code 1004, indicative of shock impedance measurements greater than 125 ohms resulting in a shorted shock, and code 1006 indicative of a high voltage detected on a lead during a device charge.There were multiple episodes of noise, non-sustained ventricular tachycardia and ventricular tachycardia, since (b)(6) 2020.The patient was admitted to the hospital to be monitored closely.The device remains implanted.No adverse patient effects were reported.Several attempts to obtain additional information on the status of this patient have been unsuccessful.Additional information was received that surgical intervention of device was performed, device explanted.It is unknown, but suspected, that a new device was implanted.Several attempts to obtain model/serial of leads have been unsuccessful.It is unknown where the location of explant occurred, and if the device will be returned.

• 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
• MDR Report Key: 11741994
• Report Number: 2124215-2021-10811
• Device Sequence Number: 3309354
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 10/18/2019
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 107467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention