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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 full prescribing 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.

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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

Last updated: 30 Nov 2011

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