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

Model Number D012

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A high-power visual inspection of the device header and lead barrels noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.A review of the device memory confirmed that the device recorded three instances of code 1009.The device was x-rayed, and no internal damage was observed, and the plasma fuse was confirmed to be intact.The device was then placed into a 37-degree celsius oven for seven hours.A manual capacitor reformation was performed, and the device again recorded code 1009.The device case was opened, and damage was observed on the dump resistor and capacitor.It appears that a piece of material, possibly solder, was on the resistor causing the short.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was explanted due to code 1009 which is indicative of that the attempted shock was not delivered due to charge timeout.No adverse patient effects were reported.

• Brand Name: INOGEN MINI ICD DR
• 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: 9204490
• MDR Text Key: 162709160
• Report Number: 2124215-2019-21373
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/13/2018
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 109395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR