Product Advisories

October 2009

Titan anchor has the potential for lead migration as a result of insert separation within the anchor

Background

Spinal cord stimulation is used to treat chronic back and leg pain. It uses a neurostimulator, which is a small, surgically placed device about the size of a stopwatch. It delivers an electrical signal to the epidural space near the spinal cord through one or more leads (special medical wires). Anchors may be used to help hold the lead in place.

What is Happening

In October 2009, Medtronic informed physicians about the potential for one type of anchor, the Titan® anchor Model 3550-39, to separate. If the anchor separates it may not hold the lead in place and may affect delivery of therapy.

If you have a spinal cord stimulation system you should consult with your doctor to determine whether you have a Titan anchor as part of your system. As always, if you notice a change in therapy, you should contact your doctor.

We are committed to answering your questions, keeping you informed, and continuously improving our products. If you have additional questions, please contact Medtronic Patient Services at (800) 510-6735, Monday through Friday, between 8 am – 5 pm, Central Standard Time.

September 2009

Sutureless Connector (SC) Intrathecal Catheters Are Not Compatible with IsoMed Constant-Flow Infusion Pumps

Medtronic recently provided doctors and patients with important safety information about the possibility of blockage or disconnection of a specific type of catheter, called the SC catheter, when used with an IsoMed^® pump.

If you have an IsoMed pump and you have concerns, please talk with your doctor to discuss whether anything needs to be done at this time.

Medtronic sent letters to patients to inform them about this issue:

icon_pdf Patient Letter for Patients with IsoMed and SC Catheter
This letter was sent to patients who have both an IsoMed pump and SC catheter registered with Medtronic.

icon_pdf Patient Letter for Patients with IsoMed
This letter was sent to patients who have an IsoMed pump registered with Medtronic but do not have an SC catheter registered with Medtronic.

Medtronic has also notified physicians and the Food and Drug Administration.

We sincerely apologize for any difficulties this may cause you and your family. We are committed to answering your questions, keeping you informed, and continuously improving our products. If you have additional questions, please contact Medtronic Patient Services at (800) 510-6735, Monday through Friday, between 8 am – 5 pm, Central Standard Time.

July 2009

SynchroMed II Reduced Battery Performance

Medtronic informed physicians about new information regarding the potential for reduced battery performance with SynchroMed^® II drug pumps with batteries manufactured during two distinct time periods prior to April 2005. The chance of this battery performance issue happening is low, but if this does happen it may affect drug delivery and a pump alarm may sound. If that happens, the pump will need to be replaced.

What is Happening

If reduced battery performance happens, the pump may need to be replaced sooner than expected and/or the drug flow rate may be reset to a very low level.

Depending on the medical condition of the patient and the medication in the pump, the effects of no longer receiving drug or receiving too little drug can vary. The effects can include a return of underlying symptoms, and the possibility of drug withdrawal symptoms. Some withdrawal symptoms can become serious if not treated promptly. Because of this, it is important that patients and their caregivers be aware of the medication in the pump, and the possible signs and symptoms of withdrawal for that medication.

Medtronic does not recommend pump replacement due to this issue unless reduced battery performance actually happens. This is because the chance of this issue happening is low, because the pump alarm sounds if there is a problem, and because of the risks associated with surgery.

Pump Alarms

Pumps have two different alarms, a three-second dual-tone alarm, and a one-second single-tone alarm. The alarms sound when:

The pump needs to be refilled.
The pump needs to be replaced.
There is a problem with the pump.

Doctors who manage SynchroMed II pumps can use their pump programmer to perform an alarm test. This test can be beneficial in reminding patients and their caregivers how the alarms sound.

As always, it is important for you and/or your caregiver to:

Be aware of the signs and symptoms of withdrawal for the medication in your pump.
Keep all scheduled refill appointments.
Contact your physician immediately if you hear your pump alarm or if you notice a change in symptoms.

Other Product Advisories

Medtronic has notified physicians about other product advisories related to drug delivery therapy and/or products. This information can be found at professional.medtronic.com