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California Probing Medtronic Heart Rhythm Devices

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Medtronic Inc. has disclosed that it received a subpoena in September from the Department of Health and Human Services’ Office of Inspector General in California regarding its heart rhythm devices.  According to The Wall Street Journal, Medtronic disclosed the subpoena in a filing with the  Securities and Exchange Commission (SEC) it had made on Wednesday.

This is only the latest subpoena Medtronic has received of late.   Last November, the company was subpoenaed by the U.S. Department of Justice over off-label use of its Infuse Bone Graft product.  Then, this past June, Medtronic was again subpoenaed over Infuse.  This time, the Department of Justice was seeking it information about  Dr. Timothy Kuklo, the former military surgeon accused of fabricating  results  for an Infuse Bone Graft study.

According to the filing, Medtronic received the subpoena on September 16.  The subpoena is seeking documents relating to revenue, sales, marketing and promotion of the company’s heart rhythm devices.  The state of California is also requesting documents relating to, among other things,  reimbursement communications to customers and documents relating to payments or items of value provided to customers.  Medtronic’s filing said it would comply with the the subpoena.

According to The Wall Street Journal, Medtronic is the  biggest player in the $11 billion global market for these implantable heart rhythm devices, including pacemakers and defibrillators.

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