Physician Letter

Physician Letter (PDF)

Important: Medical Device Correction

Consulta® CRT-D, Secura® DR/VR, Concerto® II CRT-D, Virtuoso® II DR/VR, Maximo® II CRT-D, Maximo® II DR/VR


May 2010

Dear Doctor,

Medtronic is informing you of a rare device software issue in the ICD and CRT-D device models listed above. A software update will be available to correct this issue.

As of April 19, 2010, Medtronic has received 5 confirmed reports out of approximately 144,000 devices worldwide. No patient injuries or deaths have been reported as a result of this issue. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other:

  • High voltage capacitors reach programmed energy (charge end)
  • Battery voltage measurement in-process at charge end
  • VT/VF rhythm self-terminates and therapy is aborted

In the unlikely event that this sequence occurs, all subsequent high voltage therapies will experience prolonged charge time or loss of high voltage therapy (due to a charge circuit timeout). Device alerts are nominally ON and will notify patients to seek medical attention should either of these alert conditions occur.

If the software update is not implemented, Medtronic estimates the rate of occurrence of this specific sequence of events in an ambulatory setting is 1 in 27,000 devices per year (0.000037 per year). The projected probability that a patient would need life sustaining therapy prior to a device alert being triggered for a charge circuit timeout is projected to be 1 in 291,000 per year (0.0000034 per year).

Your local Medtronic representative will assist you with installing the software on your programmer. Your patients’ devices will receive the update automatically upon their next in-clinic interrogation and their devices will be corrected.

Summary
Medtronic has identified a rare device software issue in the ICD and CRT-D device models listed above. Your Medtronic Representative will update your programmer with software Model 9995 Version 7.3. Upon their next in-clinic interrogation, patients’ devices will receive the update automatically and their devices will be corrected. Attached are the specific model and serial numbers of affected devices you are following according to our device registration records. We regret any difficulties this may cause you and your patients. If you have any questions, or if we can be of assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Sincerely,

Tim Samsel

Tim Samsel
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management

 

Medtronic encourages health care professionals and consumers to report any serious adverse affects with the use of any our products by calling Medtronic Technical Services at 800-723-4636 and FDA’s MedWatch Adverse Reporting program online or at 1-800-332-1088.125