In August 2009, Medtronic began informing physicians for the first time that, contrary to the labeling, its Sutureless Connector (SC) intrathecal catheters were incompatible with IsoMed Infusion Pump Model 8472, a drug delivery system for which the catheters were not designed. On September 14, 2009, the US Food and Drug Administration (“FDA”) notified Medtronic that it considers the notification a Class I medical device recall, the strongest notice that the FDA can issue, because accidental use of the catheters with the wrong pump may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death. This incompatibility is a design defect and not a result of how the pump is implanted. In fact, it may appear to be connected and secured, but a physical interference between the catheter and the infusion pump may lead to fluids leaking into surrounding tissues and the proper dose of drugs not being delivered.
Medtronic has received ten reports worldwide related to improper connection of the SC intrathecal catheter and Revision Kit – Models 8709SC, 8731SC, 8578, and 8596SCr – to an IsoMed Pump Model 8472. In all ten reports, medical intervention was required to correct the condition. The ten reported events included reports of underlying symptoms, withdrawal symptoms and fluid collection in the pump pocket. In one case, it was reported that a patient death occurred two days following device revision.
This is the second recall of infusions pumps that Medtronic has issued this summer. On July 10, 2009, Medtronic recalled about 3 million disposable infusion sets designed for use with its MiniMed Paradigm insulin pumps. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. In July, Medtronic estimated that about 2% of the sets from a lot number starting with “8″ may be defective.
If you have been affected by either of these recalls or would like more information about these products, please contact Pogust Braslow & Millrood for a free consultation.