Dive Brief:

• The FDA has issued warning letters to two Medtronic facilities that manufacture implantable cardioverter-defibrillators (ICDs) and other cardiovascular medical devices.

• Inspectors visited the plants in Minnesota and Puerto Rico after Medtronic urgently recalled four years' worth of devices amid concerns they may fail to deliver the required shock in the event a patient suffers a cardiac arrest or slow heartbeat.

• The FDA found Medtronic had failed to validate processes related to its ICDs, resulting in faulty devices and the urgent recall.

Dive Insight:

Medtronic indicated there were problems with the facilities producing its cardiac resynchronization therapy with defibrillation (CRT-Ds) and ICDs when it began an urgent recall in January. The recall covered CRT-Ds such as Amplia and ICDs including Evera. Medtronic told physicians who had treated patients with the affected implants to consider replacing them with a new device.

The severity of the proposed action reflected the potential harm the devices could cause. Medtronic began the recall after learning that the implants may fail to deliver an electric shock when required. If an implant failed in this way when a patient went into cardiac arrest, the fault could contribute to the death of the person.  

Inspectors at the FDA responded to the recall by visiting the Medtronic plants that made the devices. The teams found Medtronic had failed to validate ICD processes at a Minnesota plant. In Puerto Rico, Medtronic failed to establish adequate procedures for design transfer or conduct qualification. These shortcomings resulted in ICDs that “failed due to high voltage arcing” and subsequently to the recalls. The inspections also picked up on the failure to document ICDs in device history records.

The FDA detailed these issues in Form 483s and gave Medtronic a chance to respond. In the warning letter, the FDA states Medtronic’s responses "appear to be adequate." Some of Medtronic’s actions are ongoing, though, and the FDA will need to run a follow-up inspection to verify compliance.

The 483s also listed problems with corrective and preventive actions, acceptance activities, statistical techniques and inspection, measuring and test equipment. Medtronic has already resolved these issues.