Having "Lead wire" replacement Surgery?
by Frustrated & mad as hell!
On 10/22/2007 the Medtronic Co. forwarded a warning letter informing Recipients that specified Sprint Fidelis Heart moritoring Lead wires could fracture. In addition the Company notified Doctors that sale of these wires has been discontinued, unused wires are being "re-called, should be removed from shelves, and sent back to the Company.
First, this Laymans opinion is that the re-call warning notice with instructions, may prove to be comparable to a "Cease and Disist" order directed at Surgeons and associated parties.
On another occasion the Medtronic Co. suggested that a
"re-called" Lead wire may be "re-used" if found to be functioning properly. Needless to say, this concept seems to be both ludicrous and conflicting.
The observation, and concern is that the Medtronic Co. recommendation to "re-use" these questionable "re-called" lead wires may be sending the wrong message to good Surgeons, who for un-comprehended reasons resort to subjecting un-informed Patients to once again becoming involuntary "re-called" lead wire carriers. victims subjected once again to potential physical and/or emotional harm.
Finally, the suggestion to Patients requiring a pending Lead wire replacement procedure would be to exercise your "right to be informed," and insist that you be made fully knowledgeable concerning all details including the end results and risks, prior to the procedure.