For the Flex series, in this particular case the FlexSecure that is in the mail to me (happy dance!), is there a suggested “remove by” date after implant due to mechanical failure (obviously the tech has a very very long lifespan)?
I know there’s nothing prescriptive (that I’ve seen) but I’m curious if there’s an amount of time where breakdowns become more likely that, if you’re thinking conservatively, establishes a safe time boundary to pop it out to avoid polymer delamination or whatever the most likely “death due to old age” failure scenario would be.
Appart from converted credit cards, implants don’t expire.
But there is an expiration date on the pouch sterility, it’s five years after manufacturing IIRC. But as long as you get it implanted before that, you don’t have to worry about it. And DT offers the service to inspect and resterilize flex implants if you have to get it removed and want to have it reinstalled or something.
Here’s more information about the dates on the sterilization pouches:
There are a number of factors involved with expiration. Two of them have to do a memory… The data retention period, and the wirte cycle count.
Aside from that, the material will not break down. Mechanical failure is always inevitable as nothing lasts forever, but the following issues are possible;
Mechanical failure of the electrical pathways in the flexible PCB
Failure of the mob package connectors between the external metal tabs and wire bonded internal silicon die in the middle of the ABS potting
Failure of the ABS potting due to cracking or flexing it wasn’t designed to handle which causes a subsequent failure of the wire bonding between silicon die and metal tabs in the mob package frame.
Potential failure of the encapsulation if there were issues during manufacturing. This is the most difficult thing to track down. I’m sure that some people have experienced this kind of failure, but most failures are due to extreme flexing events… many of which I’m suspicious of occuring during installation.
I am currently working on a way to improve the encapsulation process and reduce some of the variability of the process. I’m also attempting to explore ways to non-destructively test each unit to ensure complete and proper encapsulation.