Product Advisories
July 2011
SynchroMed II Reduced Battery Performance
Medtronic recently provided doctors with additional information about a possible battery issue in a small percentage of SynchroMed® II drug pumps. Medtronic first told doctors of this issue in July 2009. The chance of this issue happening is low, but if this does happen it may affect drug delivery and a pump alarm will 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.
The symptoms of this issue can include a return of underlying symptoms, and/or the possibility of drug withdrawal symptoms. Some withdrawal symptoms can become serious if not treated promptly. Please see the important safety information for details. It is important that patients and their caregivers know what medication is in the pump, and the possible side effects 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 two-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:
- Always carry your patient identification card.
- 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.
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:
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.
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.
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
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