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

Model Number D140

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

Event Type  Injury  

Event Description

It was reported that device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Boston scientific technical services (ts) then suggested saving to programmer hard drive for data analysis.In addition, the patient heard the device beeping.Further, this device was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• Brand Name: INOGEN EL ICD VR
• Type of Device: 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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15154356
• MDR Text Key: 297129197
• Report Number: 2124215-2022-28766
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534201
• UDI-Public: 00802526534201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2017
• Device Model Number: D140
• Device Catalogue Number: D140
• Device Lot Number: 200050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female