Last fall, FDA inspectors visited their factory in California and came away with serious concerns. These focused upon nonconformities in their manufacturing processes, which the FDA feels could be problematic. Specifically, the FDA wants to know how St. Jude Medical monitors device safety, what kinds of records are kept, and how they address safety concerns.
Could You Be at Risk for Injury
The FDA is essentially worried that consumers may be at injury given their lack of information. Specifically, the FDA wants the following information:
- rates of injury among users in clinical trials and continuing data
- testing procedures
- corrective action procedures
- testing design verification
- multiple lead holders
According to the FDA's public letter to St. Jude Medical, these procedures are not being followed to ensure safety of its devices. If St. Jude Medical fails to provide evidence that these have been corrected, the FDA has warned the company that these devices will not be approved for use in America.
The FDA is desperately trying to asses whether or not consumers have suffered injury due to "misbranded" leads. Because reports were not submitted in a timely fashion, the FDA is unsure of whether the device has malfunctioned and potentially injured or killed people.
If You Have Been Injured
The FDA has not been able to assess whether consumers have suffered injury from the device as evidenced by their public letter available here. In an absence of this critical information, the agency is threatening to impose civil penalties and to notify federal agencies currently using the device. Consumers who have suffered injury using this device are encouraged to call the FDA to report it. Consumers should also notify a skilled product liability attorney to determine whether or not they may have a case against the manufacturer.