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U.S. Department of Health and Human Services

Medical Devices

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Medtronic Inc., Kappa 600/700/900 Series of Pacemakers and Sigma 100/200/300 Series of Pacemakers

Recall Class:
Class I
Date Recall
Initiated:
May 18, 2009
Product:

Medtronic pacemakers:

  • Kappa 600/700/900 Series
  • Sigma 100/200/300 Series

The manufacturing dates range from November, 2000 through January, 2005.

Use:
Kappa and Sigma are implanted pacemakers that provide timed electrical stimulation to the heart to treat abnormally slow heart rhythm (bradyarrhythmia).
Recalling Firm:
Medtronic Inc.
710 Medtronic Parkway, Mailstop LC400
Minneapolis, Minnesota 55432-5604
Reason for Recall:
The Kappa and Sigma pacemakers in these identified series may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
Public Contact:

Patients with Medtronic Kappa and Sigma pacemakers should determine if their pacemaker is included in this recall by contacting Medtronic at 1-800-505-4636 or by going to Medtronic’s website which is found in the Useful Links at the end of this recall notice.

For additional information, patients may contact Medtronic Patient Services at 1-800-551-5544. To read Medtronic’s Important Patient Information, see under Useful Links below.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow-up with their primary care physician or cardiologist.

Physicians should contact their local Medtronic representative or Medtronic Technical Services at 1-800-505-4636.
 

FDA District:
Minneapolis
FDA Comments:

In May 2009, Medtronic sent letters to physicians and to patients with the affected Kappa and Sigma pacemakers. The company's June 10, 2009 news release and these letters contain the following recommendations:

Patients:

  • Contact Medtronic (see above) to determine if your pacemaker is included in the affected group.
  • Contact your physician if you have one of the affected pacemakers.
  • Seek medical attention immediately if you experience symptoms such as fainting or lightheadedness.

Physicians:

  • Advise patients to seek medical attention immediately if they experience symptoms such as fainting or lightheadedness.
  • Consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets.
  • Continue routine follow-up in accordance with standard practice for those patients who are not pacemaker dependent.

Medtronic will offer supplemental device warranty if the device is not yet ready to be replaced.

The letter also provides physician and patient support. Letters were mailed to patients with registered devices beginning on May 27, 2009.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program. See below to access the MedWatch website.

Useful Links:

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