Vendor B and ICS Warranty Updates

Question 1

When did VendorB implants stop being produced by AB?

Answer 1

Feb 2006

Question 2

Moisture was getting into the Vendor B devices, causing some failures. Where was the moisture coming from and how was it getting into the devices?

Answer 2

• Moisture leaked in

* Source was attributed to the feedthru manufactured by Vendor B

Question 3

What are the 3 issues that are not covered under the initial 10 year warranty period for ICS?

Answer 3

• medical cause
• head trauma
• medical provider cause

Question 4

How an you tell if a device is vendor B?

Answer 4

• HiRes 90K implant manufactured between 2003-2/2006 containing vendor B feed thru
• If device has 20 year warranty coverage
• check the documentation!

Question 5

What does RCC stand for? What do they do?

Answer 5

Recipient Care Committee

They make warrant decision (preview potential device explant and or explant reporting form)

Question 6

If vendor B 90K device was implanted on 7.4.2005 and failed on 12.15.2014,

is it still under warranty?

Answer 6

Yes

Question 7

If vendor B 90K device was implanted on 7.4.2005 and failed on 12.15.2014,

If patient was revised with HiRes90K on 12.15.2014, when does the warranty expire?

Answer 7

12.15.2024

Question 8

If vendor B 90K device was implanted on 7.4.2005 and failed on 12.15.2014,

If the device didn’t fail, when would have warranty expired?

Answer 8

7.4.2025

Question 9

How are device failures confirmed?

Answer 9

requires failure analysis testing in Valencia HQs

Question 10

When did AB initiate voluntary recall of HiRes 90K after observing small number of failed devices due to moisture?

Answer 10

Sept 2004

Question 11

What happened after the voluntary recall?

Answer 11

• AB improved manufacturing processes to ensure moisture wasn’t sealed in
• early 2006, AB discovered several explanted devices with elevated moisture levels
• believed moisture wasn’t sealed in but was leaked in from feed thru, with overwhelming majority from Vendor B

Question 12

When did AB stop using Vendor B feedthrus?

Answer 12

2006

Question 13

When did AB initial voluntary recall of unimplanted Vendor B HiRes90Ks?

Answer 13

March 2006

Question 14

Helium Leak Testing Feedthrus

Answer 14

Used Helium leak test to ensure feed thru didn’t allow water to pass through (helium is smallest element, so if that can’t get through, nothing else should be able to either)

Question 15

How did Vendor B feedthrus leak in moisture?

Answer 15

• Overtime, vendor B feedthrus’ glass had voids/porous properties
• Pores have the potential to be filled with water, which can block the helium from passing through, and defeat effectiveness of helium leak test

Question 16

What does AB include in their Cumulative Survival Rate (CSR)?

Answer 16

includes all explants (excluding medical reasons); including explanted from a failure, if freaked out and wanted explanted, etc.

other companies may just include failures

Question 17

How much warning that Vendor B device is going to fail?

Answer 17

once symptoms begin, moisture related implants tens to fail within few days to few weeks

Question 18

Vendor B time to failure

Answer 18

90% of failed devices have failed within 6.1 years of implantation

On average, Vendor B devices have failed within 3.2 years after implantation.

Question 19

Symptoms of Vendor B Failures

Answer 19

• complete loss of lock or intermittent lock
• overly loud sound (OLS) or popping
• sudden sensation of discomfort or pain
• sound quality or performance issues
• zero impedances in the fitting software

Question 20

How to confirm vendor B status

Answer 20

email issues@advancedbionics.com