A growing number of clients are reporting pacemaker defects where the leads have caused:-
- Inappropriate shocks
- Loss of defibrillation therapy
- Loss of pacing output
Some clients who have reported these pacemaker defects have been given a magnet to carry around with them so that if the faulty lead induces an unnecessary shock, they can hold the magnet over the pacemaker site to stop it. We are keen to hear from any patients who have been affected by this.
On 19th October 2007 Medtronic Inc released a Medical Device Alert to all NHS Trusts and the Healthcare Commission warning of problems experienced by patients fitted with the Sprint Fidelis implantable cardioverter defibrillator (ICD) lead (manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949).
The ICD lead recall was due to a risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by the fracture of the lead conductor.
The Alert specified:-
- Do not implant any of the Sprint Fidelis ICD leads (models listed above)
- Identify and return to Medtronic any of these leads which have not been implanted
- Identify all patients implanted with affected models and arrange a follow-up as soon as practicable (within 8 weeks)
- Ensure programming parameters are set to maximise the chance of detecting lead fractures and avoiding inappropriate therapy (in accordance with manufacturer’s advice)
- Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any audible patient alert
- Follow up patients at 3-month intervals
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