Video originally created by FDA -- posted by Lawsuit.com on December 14, 2009

Medtronic Neuromodulation is alerting healthcare professionals and patients that the company’s Sutureless Connector (SC) catheters and revision kits are not compatible with IsoMed implantable infusion pumps.

The product labeling incorrectly stated that SC catheters were compatible with IsoMed pumps. This was corrected in an August 2009 letter to healthcare professionals. The letter explained that SC catheters are not compatible with IsoMed pumps because the catheter may not connect completely to the pump, even if it appears to be securely connected. If that happens, the catheter may become disconnected from the pump, or an occlusion may occur at the connection site. This could result in tissue damage if a drug or cerebrospinal fluid leaks into surrounding tissue. Patients could also experience a loss of or change in therapy, a return of underlying symptoms or a serious or even fatal drug underdose.

Medtronic’s letter cautions that the SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps, but once an SC catheter has been connected to an IsoMed pump, the catheter connector may be permanently damaged, which could then prevent the catheter from connecting properly to a SynchroMed pump.

Here are the company’s recommendations:

• For future revisions and implants, do not use SC catheters with IsoMed pumps. Also, do not connect a SC catheter that was previously connected to an IsoMed pump to a SynchroMed pump because the catheter connector may have been permanently damaged.

• If an SC catheter is, or has been, connected to a patient’s IsoMed pump, use clinical judgment to decide if prophylactic revision is warranted.

• If a disconnection or occlusion occurs, revision will be necessary. Note that patients who have had their therapy interrupted for any reason may be effectively drug naive at the time they undergo revision. And so they may be at risk for drug overdose after their revision surgery. So practitioners should follow the initial dosing and patient monitoring recommendations in the drug labeling.

• Continue to educate patients and caregivers to recognize the signs and symptoms of drug underdose and withdrawal, and to seek medical help immediately if they occur.