Letter to patients with the Medtronic Sprint Fidelis ICD Lead

Dear Sir/Madam,

Our records indicate you were the recipient of a Medtronic Sprint Fidelis defibrillator lead.  A recent clinical advisory from Medtronic was issued regarding this lead.  This advisory was issued because a higher then normal rate of spontaneous fractures were seen to occur in some of the electrical conductors inside this lead.  This lead is no longer being manufactured by Medtronic.  Should a fracture develop in your ICD lead, it is possible that you will receive a sudden shock or series of shocks from the defibrillator despite being in normal rhythm at the time of the shocks.  We are recommending that all patients who have this lead make an appointment with either our office or their cardiologist’s office.  At the time of the appointment, your defibrillator will be reprogrammed to help minimize the risks for inappropriate shocks and we will give you specific advice regarding what your options are with regards to leaving this lead in place versus electively replacing this electrode. More information regarding the latest recommendations we have on this issue can be found on our website at www.heartrhythmcenter.com.  Please make an appointment with this office as soon as practical.

Sincerely,

Robert S. Fishel, MD FACC

Faren Angella , MD FACC

Vladamir Rankovic , MD FACC

Mark Freher, MD FACC

Daniel M. Beyerbach, MD FACC