Medtronic Deep Brain Stimulation (DBS) Lead Caps

In February of 2013 Medtronic issued an Urgent Medical Device Correction notification to inform physicians that their deep brain stimulation (DBS) lead caps had the potential to become “damaged due to twisting of the connector within the lead cap during the surgical procedure.”  These lead caps are found in the Medtronic DBS lead kits and dystonia therapy kits.  The FDA reviewed the Urgent Medical Device Correction notification of Medtronic’s deep brain stimulation (DBS) lead caps and on May 2, 2013 decided to classify it as a Class I recall.

What Is a Class I Recall?

Class I recalls are the most serious types of FDA recalls.  Class I recalls are used to recall dangerous products that are reasonably certain to cause serious health problems or even death.

What Is Medtronic’s Deep Brain Stimulation (DBS) Therapy Used For?

According to the FDA, Medtronic’s Deep Brain Stimulation (DBS) therapy is used for the following:

  • DBS therapy delivers mild electrical pulses to areas of the brain.
  • In Europe and the United States, DBS therapy is used for the treatment of the “disabling symptoms of essential tremor, advanced Parkinson's disease and chronic intractable primary dystonia.”
  • In Europe, Canada and Australia, DBS therapy is “approved for the treatment of refractory epilepsy.”
  • In the European Union and in the United States, DBS therapy “is approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder.”

Recalled Product Information:

  • Recalling Firm: Medtronic, Inc.
  • Class I Recall Classification Date: May 2, 2013
  • Reason For Recall: There have been reports of the DBS lead caps being damaged “due to twisting of the connector within the lead cap during the surgical procedure.”
  • Which kits are the DBS lead caps included in? The DBS lead cap is included in DBS lead kits and dystonia therapy kits
  • What are DBS lead caps used for? DBS lead caps are sometimes used to protect the end of a DBS lead after it has been implanted.

Click for more information about the Medtronic Deep Brain Stimulation (DBS) Lead Cap recall.

Additional Information:

If your physician used the Medtronic Deep Brain Stimulation (DBS) Lead Cap on you, you are encouraged to ask your physician any questions relating to this issue.  Moreover, if you have experienced any malfunctions or adverse events related to Medtronic Deep Brain Stimulation (DBS) Lead Cap, you should report it to Medtronic Neuromodulation Technical Services at 1-800-707-0933.

What to Do if a Recalled Product Has Affected You:

If you or a loved one has suffered injuries as a result of a recalled product, you may be entitled to compensation.  It would be beneficial to speak to an attorney specializing in products liability.  Most of the attorneys here at LawInfo.com offer free initial consultations.  It would be advantageous to at least discuss your case with an attorney to get some feedback.