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AMS 800 Control Pump - Artificial urinary control system

Safety advisory

26 March 2013

Health professionals and consumers are advised that selected lots of AMS 800 Control Pumps may not function as intended by the manufacturer, American Medical Systems Inc (AMS).

AMS 800 Control Pumps are used in artificial urinary control systems, which are implanted in patients with moderate to severe incontinence to simulate normal urinary function.

Image of the AMS 800 Control Pump. Showing the pressure regulating balloon; control pump bulb and cuffOnce implanted and activated, squeezing a bulb on the control pump releases the pressure exerted by a cuff that otherwise closes off the urethra. After urination, the cuff refills and restores urinary control. The device is deactivated when initially implanted for a period of 4-6 weeks to allow the patient to heal. It can also be deactivated if necessary, for example if the patient needs a catheter.

Investigations undertaken in response to customer complaints have found that selected lots of two models of control pumps supplied in Australia were released despite not fully meeting the manufacturer's product release criteria.

The item numbers for the affected models are:

  • 72400098
  • 72404127.

All affected stock has been removed from the field.

The investigations found that following issues may be encountered when using the device:

  • increased force is required when squeezing the bulb to initially activate the device after implantation, or reactivate it after being deactivated for whatever reason
  • unintentional filling of the cuff despite the device being previously deactivated
  • increased force is required when squeezing the bulb to deflate the cuff during normal use.

If these issues occur, patients could experience one or more of the following symptoms:

  • mild bruising at the site of the pump
  • incontinence
  • inability to urinate and subsequent symptoms/complications of urinary retention, which can pose serious health risks.

Information for consumers

If you have an artificial urinary control system and experience any of the above issues, or if you have any general questions or concerns about such systems, contact your health professional.

Information for health professionals

Patients with symptoms that suggest their artificial urinary control system is not functioning as intended should be referred to a urologist, preferably the implanting urologist.

Information for urologists

Urologists who have implanted an AMS 800 Control Pump from one of the affected batches should have received written advice from AMS and are advised to review that information closely.

If a patient experiences any of the symptoms outlined above, urologists should consider appropriate actions including, but not limited to, revision surgery.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.