Medtronic defibrillator Patients: Recall of Sprint Fidelis Leads
Medtronic issued a press release on a voluntary recall of the Sprint Fidelis® family of defibrillation leads, due to the potential for lead fractures. Medtronic is recommending that Doctors do not use implants of the following Sprint Fidelis Model leads: 6930, 6931, 6948, 6949. Approximately 268,000 Sprint Fidelis leads were implanted worldwide. They are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). This action does not affect Medtronic pacemaker patients.
According to Medtronic there are approxomately five deaths linked to lead fractures. A lead wire connects an implantable defibrillator to the heart. If it breaks, the defibrillator can cause a massive and painful shock. A fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. It is risky to replace a lead, since it requires invasive surgery that can cause the tissue of the blood vessels and heart to tear. Itt is recommended that defibrillator leads are not to be replaced due to the risk it may cause patients, unless they fracture.
According to FDA reports, "the FDA will continue to monitor information on these devices and will take whatever other actions may be necessary."
To read more on the Medtronic Sprint Fidelis Lead Recall
FDA Medtronic Sprint Fidelis Lead Recall Info
Medtronic Sprint Fidelis Lead Recall News Release
