In August of 2007, the Medtronic Neuromedulation Company sent a letter to each of its customers. The top of the letter displayed this phrase: “Urgent Medical Device Correction, August 2007.” The letter disclosed some unsettling information about the SynchroMed EL infusion pumps.
The letter sent a clear warning to all those who had purchased a SynchroMed EL infusion pump prior to September of 1999. Mounting evidence had produced proof that pumps made before that date could stall at an unexpectedly high rate. The wear and tear on pumps made before September of 1999 could result in a sudden stoppage of delivery. Stalled pumps ceased delivery of insulin.
The letter emphasized the importance of its message. It indicated that the recall of the SynchroMed EL pump was a Class 1 recall. Any recall constitutes an action taken to address a problem with a product. The FDA can call for the recall of a medical device. A Class I recall underlines the harm that could result from continued and widespread use of a medical device with a particular problem.
The actual recall process had been initiated by the Medtronic Neuromedulation Company. As indicated, the Company had sent letters to each of the customers who had purchased a SynchroMed EL infusion pump. The Company had also completed another important step in the recall process.
When a company recalls a medical device, it needs to do more than just contact those who have previously purchased that device. It also needs to forewarn any customers who might now be thinking about buying that device. When a Company initiates the recall of a medical device, it must also put out a press release. In that release it must make clear what the name of the device that has been shown to be a potential threat to users of that device.
The Medtronic Neuromedulation Company had released such a statement to the press. It had also distributed information that could help customers to better identify the problem pump. Finally, the Company had acted to make the necessary changes in the pumps, changes that would eliminate any potential harm to a diabetes patient who was using that same pump.
The FDA led oversight of the actions taken by the Medtronic Neuromedulation Company. The FDA worked with Company officials to get out clear and complete information on the product that was being recalled. In addition, the FDA had asked the Company to issue a public statement, a statement outlining its recall strategy.
Once the Company had initiated its proposed recall strategy, then the FDA had conducted an audit of the Company. The FDA used that audit as a way to judge the effectiveness of the ongoing recall. The FDA also took steps to monitor the efforts being made to correct the device deficiencies, the deficiencies that had led to the recall.
Although the FDA has designed the recall process to limit the number of consumer concerns, the Agency realizes that some customers might still have questions. For that reason, it has announced several channels by which concerned customers, possibly diabetes patients, can direct their questions to those most apt to have the correct answer.
Diabetes patients who use or have used the SynchroMed EL infusion pump can obtain more information by calling 1-800-707-0923. They can also go online to this website: www.fda.gov/MedWatch/report.html. A diabetes patient who can not make a phone call or does not have access to a computer has yet another option. He or she can send a Fax to 1-800-FDA-0178.
Should a diabetes patient care to mail a letter to the executives at the company conducting the recall, then that patient should address that letter to:
Medtronic Neuromedulation Company
800 53rd Ave. N.E.
P.O. Box 1250
Minneapolis, Minnesota 55440-1250
