Defibrillators

The FDA re-inspected Guidant's cardiac rhythm management or CRM facility in St.

Paul, Minnesota between November 9 and December 7, 2006 and noted no observations.

The re-inspection included an assessment of Natick, Massachusetts-based Boston Scientific's implementation of quality system improvements in response to the warning letter.

Due to the sanctions, export or approval of new models of Paul, Minnesota had been barred.

The U.S.

regulators had said earlier that loose particles inside the crystal components of the device caused 35 confirmed failures of the Insignia line of pacemakers.

While patients were not informed of the possibility of failure while using Insignia pacemakers, the company also failed to warn doctors in time about software glitches that led to some pacemakers quitting.

A total of 49 Insignia failures were cited by the FDA, which criticized Guidant's quality-control system as well as record-keeping.

Commenting on the development, Jim Tobin, President and Chief Executive Officer of Boston Scientific, said: "We are very pleased with the FDA's conclusion.

This achievement is the result of a lot of hard work by employees across our CRM organization.

The improvements made to our CRM quality sy...

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