2025 October FDA Received AMS 700 Adverse Events

[lasthope2.0]

Attached - 2025 October FDA Received AMS 700 Adverse Events

Limited Mechanical Event Stats:
Only 41 out of 119 mechanical events (59%) out of 202 total events had both event date and manufactured date.
Assumption: 1 year adjusted for shelf life.

Min: 2 months
Max: 12 yrs (Congratulations! 66 year old individual with LGX from South Korea. Event - Crack on pump connecting tube.)
Mean: 4 yrs
Median: 3 yrs

Sources:
-U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database.
https://www.accessdata.fda.gov/scripts/ ... search.cfm

Disclaimer: MAUDE data is a passive surveillance tool with reporting limitations and should not be interpreted for causality.

[Thisworld]

Great work!
The average and median are calculated for mechanical events only , without considering infections and others biological issues, right?

[lasthope2.0]

Great work!
The average and median are calculated for mechanical events only , without considering infections and others biological issues, right?

Thank you, Thisworld. Yes, those are for mechanical events only. Many mechanical event reports had missing 'Date of Manufacture', so the observed mechanical events sample for the min/max/mean/median reduced to 41.

I have re-attached the Gemini high level summary PDF file after fixing an error. This is easier to digest compared to the tedious excel file. I've also included a high level failure mode summary and a note about Mayo Clinic's THALIA technique referenced for preventing reservoir migration.

[gregorbehr]

Great work!
The average and median are calculated for mechanical events only , without considering infections and others biological issues, right?

It would be interesting what has been reported to them that would fall under the notion of biological issues.

[lasthope2.0]

Great work!
The average and median are calculated for mechanical events only , without considering infections and others biological issues, right?

It would be interesting what has been reported to them that would fall under the notion of biological issues.

For biological, AMS 700 events have this list (see attachment) listed as 'Patient Problem'.

Malposition, Migration and Sizing issues are reported as 'Device Problem' even if biological factors like tissue compliance, anatomy and surgical competency play a key role. Atleast I try not to count them as mechanical!