Medtronic, Inc. Releases Patient Safety Information on Specific Subsets of Kappa® and Sigma® Series Pacemakers

According to a patient safety information letter released May 18, 2009, specific subsets of Kappa® and Sigma® series pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components components (e.g., battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output. Medtronic is communicating this information to the appropriate regulatory agencies.

Read the Medtronic, Inc. Physician Letter (PDF, 74K), which discusses this new Kappa and Sigma issue, offers a performance update to 2005 Sigma advisory, a summary of affected devices and patient management recommendations.

Medtronic will provide regular updates at its Product Performance Report, available at www.medtronic.com/crm/performance.

Physicians with questions are asked to contact their local Medtronic Representative or Medtronic Technical Services at 1 (800) 505-4636.

UPDATE 6/10/09: Learn more »