The Medtronic Sprint Fidelis model 6930, 6931, 6948, and 6949 leads have been identified as a fracture risk. When fractures occur, the Sprint Fidelis defibrillation leads can deliver unnecessary shocks or no shocks at all.
In an Urgent Medical Device Information update, Medtronic has issued Patient Management Recommendations for Sprint Fidelis Leads.
October 15, 2007, in a letter to doctors, Medtronic wrote to provide important information on Sprint Fidelis leads.
Where Medtronic's records indicate that a model 6930, 6931, 6948 or 6949 lead was implanted, Medtronic has written to the doctor to make recommendations for ongoing patient management. Medtronic has advised that they have voluntarily suspended distribution of Sprint Fidelis leads worldwide and are telling doctors to stop using Sprint Fidelis leads.
What is broken?
This recent warning (October 2007) follows Medtronic's report in March of 2007 that chronic conductor fractures have occurred on Sprint Fidelis leads. The locations on the wire are the the distal portion of the lead, which affects the anode and near the anchoring sleeve tie-down, predominantly affecting the cathode. These conductor fractures can result in the inability of the heart device to deliver defibrillation therapy.
Medtronic has also confirmed 665 chronic fractures in returned leads. Most of the fractures occurred in the anode or cathode conductors. But there is also a risk of fractures in the high voltage conductors.
What are the symptoms?
It is not so simple to know whether this has occurred since there are multiple clinical presentations. For example, it may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output.
How dangerous is this?
Medtronic is aware as of Oct 15, 2007, of five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.
How can your doctor reduce the risk?
Medtronic recommends that doctors conduct routine follow-up for each patient and possibly that changes be made to the settings to help the doctor detect if a fracture has occurred.
These steps, Medtronic believes, can reduce the risk of inappropriate detection and therapy due to over-sensing. These steps may also help optimize effectiveness of the lead impedance alerts. Medtronic believes that doctors taking the right actions can increase the likelihood that a fracture will be detected by Patient Alert and/or Medtronic CareAlert notifications and decrease the likelihood of inappropriate therapies.
As of October 2007, based on Medtronic's review of available data, they have told doctors that there does not appear to be a benefit to more frequent follow-up. You should consult your doctor to find out if they have reviewed the most recent information from Medtronic and to give you advice accordingly.
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If you or someone you know has received a defibrillator with Sprint Fidelis leads (implants since 2004), please contact our offices for a free case evaluation.