Lead wire question:

I had a Pace/Defib replacement procedure recently. An original connected Lead wire was a Re-call, and declared non-usable by the Medtronic Corporation.
Should I be concerned that the Doctor while performing the procedure attached the questionable original Re-called Lead wire to the new device, anybody ever heard of this being done before?

3 Comments

Good question

by ElectricFrank - 2012-01-17 10:01:09

Two things you can do.
1. Call Medtronics and ask them about the situation. Since it was them who sent out the recall they will have all the info.

2. Based on the results of the Medtronics call get in tough with the doctors office and see what they have to say. Expect to get the run around and be ready to get a bit pushy if necessary.

There may also be a good reason for what they did.

frank

stay calm

by samuelh - 2012-01-18 12:01:20

The recall is because of the failure of a very ,very small percentage of leads.What one may legitamately question is the issuing of a recall as a method of resolving a very serious failure on medtronics part to properly test a product.Removing and replacing a lead is a very serious bit of surgery with many inherant risks including death.Recalling a lead is not like recalling your Toyota.You need to have regular pacemaker monitoring to check that all is in order.Leads do not tend to fail all at once but over time and this will show in the regular testing.So try not to worry and if it "aint broke dont fix it".
sam

"Re-called" lead was reused!

by Dixie - 2012-01-29 10:01:01

I called the Medtronic Co. and asked what they had to say about a "re-called" Fidelis lead being connected to a new P/D during a replacement procedure.

The Represenative replied that it was the "Doctors decision" and would not comment further.

I called the Doctors Office and asked why he connected the questionable lead to the new P/D, his reply via a Receptionist was "so far his lead continues to work fine, and continues to function normally".

Suggestion, In interest of peace of mind and safty, when it becomes necessary to make surgical changes involving a P/D or lead wire, be sure to ask the Doctor if an already implanted "re-called" lead wire is going to be reused!

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