Warning Letter: Devicemaker Must Report Foreign MDRs

Sorin Biomedica must report adverse events involving its devices that occur outside the U.S. to the Center for Devices and Radiological Health (CDRH) if the devices are marketed in this country, according to a warning letter.

During an inspection of Sorin’s Saluggia, Italy, plant June 29 through July 2, CDRH discovered complaints from Belgium, Britain, France, Germany, Greece and Japan about the company’s Isoline defibrillation leads used in implantable cardioverter defibrillators and pacemaker systems.

Although the device is marketed in the U.S., the incidents were not submitted to the FDA as medical device reports, according to the Oct. 29 warning letter.
The GMP Letter