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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic Recalls

On March 21, the FDA announced a Class 1 recall for Medtronic Neuromodulations implantable infusion pumps.

Affected devices include: SynchroMed EL (models 8626-10, 8626-18, 8626L-10, 8626L-18, 8627-10, 8627-18, 8627L-10, and 8627L-18), SynchroMed II (models 8637-20 and 8637-40), and IsoMed (models 8472-20, 8472-35, and 8472-60).

The recall is based on reports of inflammatory mass (granuloma) formations at or near the distal tip of intrathecal catheters that are used to infuse baclofen, opiods, or chemotherapy drugs, according to a safety alert issued by MedWatch, the FDA's safety information and adverse event reporting program.

In a letter to healthcare professionals, the company noted that the reported incidence of inflammatory mass with intrathecal drug delivery has increased 5-fold from 2001 to 2007 (0.49% vs 0.1%) and is expected to continue increasing. Symptoms most commonly include decreased therapeutic response/inadequate pain relief (33.5% of cases), pain (32.6%), and neurologic deficit/dysfunction (17.4%).

Due to the risk for inflammatory mass appearing over time and increases with larger doses and/or concentrations of opioids, the lowest dose and concentrations are recommended.

Those patients that receive intrathecal baclofen therapy for spasticity should be monitored closely for prodromal clinical signs and symptoms of inflammatory mass, specifically while using pharmacy compounded medications.