Medtronic at it again…This time it’s their Pain Pumps
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Having been involved in intra-articular pain pump litigation for some time I was quite familiar with the devastating injuries these pumps can cause . The most commonly associated injury is Post Arthroscopic Glenohumeral Chondrolysis (PAGCL). I am also familiar through involvement in other Medtronic product litigation that this company has had significant issues with design and manufacturing quality issues.
I was not however, prepared for the shocking injury suffered by a new client who experienced high level paraplegia due to a defective Medtronic SynchroMed permanent pain pump.
For those who don’t know, the FDA has issued a class one recall for Medtronic SynchoMed and IsoMed pain pump systems. It seems that contrary to self-reported complication rates, the true rate of serious complications associated with the use of these products is staggering.
One such underreported complication is the development of granulomas at the catheter tip. When that tip is placed in the intra-thecal space, the development of a granuloma poses the risk of spinal cord compression and compromise. Any patient who suffers this complication is at risk of serious, permanent injury if they do not receive immediate, impeccable care which as we all know is less than universal. Why place consumers at such risk?
These pain control systems are widely used and universally touted by manufacturers as safe alternatives to oral, narcotic pain medication. However, with the widespread failure of numerous mechanical pain management systems, physicians and consumers should be on high alert. If destroying joints was not bad enough, paralyzing consumers simply to avoid exposure to oral pain meds is unacceptable. Enough is enough.
I hope thinking people are feeling less and less confident in basing preemption of state law on the supposed safety of FDA approved products. This is yet more evidence to the contrary.