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FDA Complaint regarding Medtronic PS Medical Strata Shunts

Date: January 30, 2008

    Last year, we filed a complaint with the Food and Drug Administration over marketing claims and mis-use of the Strata shunt by Medtronic. We provided correspondence how the company is misleading neurosurgeons as to the required surgical placement considerations with its anti-siphon Strata programmable shunt. An incorrect surgical placement on the head of a user patient can lead to poor outcomes, chronic complaints, and unnecessary reoperations. It can give rise to a syndrome, appropriately termed the "Shunt Disability Sentence."

    The above 11-page file includes company claims in opposition to their own labeling and user instructions. On Page 1, Bill Sugleris writes, "shunt placement is not as critical because his neurosurgeon can change the pressure of the valve." On Page 2, Bill Sugleris writes "that the valve body should be placed somewhere behind the ear." Then, Page 5 and Fig 13 reveal the importance of placing the Delta chamber on or near the same vertical plane as the ventricular catheter tip. The "solid line" in Fig 13 indicates how CSF flow is restricted to as little as a few ml/hour, with its anti- siphon action in upright posture when the Strata is placed 3 - 4cm above the tip of the ventricular catheter. NOTE: The CSF flow rate in the upright posture CANNOT be increased by lowering the opening pressure of the valve once placement site and anti-siphon reference has been incorrectly surgically fixed. On Page 6, a Medtronic clinical study states how "extreme care" should be taken in positioning the SCD in line with the tip of the inlet catheter. Pages 7 - 11 then contain previously published and conflicting "Comments" from neurosurgery journals (per a 1996 FDA Petition) by physician Dr. Harold Portnoy, co-inventor of the SCD device and shareholder of the company.