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Summary of FDA Perspective

• individual patient’s informed decisions
• the care and advice of their expert physicians
• timely, accurate, updated, complete information
• clear communication

Example: Telectronics Accufix Lead

Especially at recalls…
FDA recognizes and supports:

…all FDA efforts support these…first.

Patients’ needs determine what requires attention.
But how?

The most critical device functions provide the key link. ex:

• survival functions
• timely functions

the most critical functions + the patient’s needs = what needs attention

So, different patients may depend on the same device for very different needs, and…

Different patients may have very different needs all within a single recall!

Consider:

• failure of an atrial lead in a pacemaker patient with chronic AF
• failure of pacing in an ICD with adequate NSR and normal conduction

FDA recognizes that the most critical or timely device functions need the most attention when considering all recall patients as a group

…and that care of individual patients is considerably more complex

Informed Decisions: individual perspective

• draw on their own experiences
• ask questions
• enlist expert physician help
• consider what they have learned about treatment risks, benefits, the balances and the alternatives
• ask “What would the doctor do if they were me?”
• revisit, revise and rethink things
• require clear communications
• check comprehension

FDA’s informed decisions are similar:

• experience helps
• questions help
• consultations occur
• treatment risks, benefits, balances and alternatives are considered
• updates are expected
• communications must be clear
• information = care

But care is different than managing a recall:

• care is individualized, episodic, fluid, ongoing, evolving
• care is person to person
• individuals approach different issues differently
• implants are long-term, so
  • removal has its own risks
  • urgent removal may not be helpful
  • issues with the PG may be addressed at change out
  • lead issues are more complex
• recalls must address all affected individuals

Real Life example: the Accufix Lead

Issue:

• fracture and protrusion of a shaping element
• 3 Accufix “J” lead models
• 41,000 implants worldwide
• 6400 patients are still living with the lead today
• all leads are now at least 10 years old
• two deaths and two cardiac tamponades were originally noted

Action:

• recall; sales halted; intensive tracking of affected patients
• independent review group formed
• intermittent updates and recommendations published

Challenge:

• low long-term risk of death and cardiovascular perforation noted
• larger risks were associated with explanting the lead

Lessons Learned:

• not all recall devices require removal
• removal may be associated with its own risks
• there is no substitute for long term follow-up data

Updated September 16, 2005

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