Medtronic lead recall/sprint fidelis

• by bunnykin
• 2008-06-19 01:06:38
• 1008 views
• 0 comments

Hi PM/ICD friends,
For those of you who have like me an ICD ventricular lead on recall, either models: 6949, 6948, 6931, 6930; If you have the time or if you haven't looked into the Medtronic site, there was an update of Sprint Fidelis lead Performance etc. Letter was dated May 7, 2008. ( Letters both to Doctors and patients). Do go into the appendix II, III and IV; Interesting to know that Alert from lead fracture given to patients have been noted to be: (under the Advance Notice section) 49% of patients who experience a lead fracture will receive more than 2 days notice. The remainder of the patients will receive less than 2 days notice or no notice! How about that?
There's another projection of clinical experience/hypothetical clinic of 1000 Fidelis lead patients & what is projected over the next 12 months.
Thank God Medtronic apparently would have developed by late
this year a new software that can be downloaded into approx. 93% of implanted devices worldwide(98% in US), to increase early detection of the likelihood of lead fracture even before inappropriate therapy. Now let's all who are affected just pray hard that those figures don't keep going up and hope that most of us will get a chance to have that software downloaded to safeguard untoward consequences esp. for those who are PM dependent... of which I'm one of them :(
Can't imagine collapsing in the midst of an important meeting in the office without enough warning/alarm from our device when lead fractures. How awfully frightening!
Approx. 75% of patients they say should get 3 or more days notice with the new software. All the best to you my friends, and to those who are intermittently troubled by nonsustained VTs detected by your ICDs do take extra care & get your EP to check/interrogate. "Vivere" (dare to live).
Warm regards. Bunnykin