S-ICD - subcutaneous implantable defibrillator
S-ICD or subcutaneous implantable defibrillator
I had my S-ICD implanted in Oct 2012. Special permission was needed as they were not approved then. There is little data proving or disproving them and nothing long term yet on either the box or the leads. While undergoing the implant surgery the first unit failed. The error that caused it helped to trigger a world wide alert on them. A relatively simple surgery was complicated by this.
My pain post op was horrendous. I was not able to do the x-ray the next day I hurt so bad. It was BAD.
As time went on some pain resolved but most didn't. I am about 18 months post implant now. My torso area is numb, yet my back area alternates between intense stabbing pain to hot burning pain. I'm told it's nerve damage. It "may" resolve at the time of battery change but most likely it will remain permanent. My range of motion is severely compromised. Bending to get stuff in bottom cupboards or fridge is intense agony. Trying to lift things into or out of microwave is so painful. 24/7 no breaks ever from pain. I cannot sit in a hard backed chair, I cannot lay or sleep on my back from the pain.
I did have a regular ICD originally but contracted a near fatal blood infection from that placement. Stuff grew on leads and I was not expected to survive removal of it.
Maybe my body had had enough crap by the time I got the S-ICD.
It doesn't pace, batteries are short term (less than 5 years) which means much more frequent surgeries with risk of nerve damage, no improvements have yet been announced, there is no long term data available, there are few experienced implant surgeons.
I was the 5th in Canada to receive one. There are few hospitals that have the ability to interrogate it, there are no remote capabilities,
DFT testing was not done due to the complications during surgery, so I really don't even know if this thing inside me works.
I know I may one day need it, but at the same time it has compromised my life so much.
This from USA food and drug admin:
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
I had my S-ICD implanted in Oct 2012. Special permission was needed as they were not approved then. There is little data proving or disproving them and nothing long term yet on either the box or the leads. While undergoing the implant surgery the first unit failed. The error that caused it helped to trigger a world wide alert on them. A relatively simple surgery was complicated by this.
My pain post op was horrendous. I was not able to do the x-ray the next day I hurt so bad. It was BAD.
As time went on some pain resolved but most didn't. I am about 18 months post implant now. My torso area is numb, yet my back area alternates between intense stabbing pain to hot burning pain. I'm told it's nerve damage. It "may" resolve at the time of battery change but most likely it will remain permanent. My range of motion is severely compromised. Bending to get stuff in bottom cupboards or fridge is intense agony. Trying to lift things into or out of microwave is so painful. 24/7 no breaks ever from pain. I cannot sit in a hard backed chair, I cannot lay or sleep on my back from the pain.
I did have a regular ICD originally but contracted a near fatal blood infection from that placement. Stuff grew on leads and I was not expected to survive removal of it.
Maybe my body had had enough crap by the time I got the S-ICD.
It doesn't pace, batteries are short term (less than 5 years) which means much more frequent surgeries with risk of nerve damage, no improvements have yet been announced, there is no long term data available, there are few experienced implant surgeons.
I was the 5th in Canada to receive one. There are few hospitals that have the ability to interrogate it, there are no remote capabilities,
DFT testing was not done due to the complications during surgery, so I really don't even know if this thing inside me works.
I know I may one day need it, but at the same time it has compromised my life so much.
This from USA food and drug admin:
Subcutaneous Implantable Defibrillator (S-ICD) System - P110042
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Subcutaneous Implantable Defibrillator (S-ICD) System
PMA Applicant: Cameron Health, Inc.
Address: 905 Calle Amanecer, Suite 300, San Clemente, CA 92673
Approval Date: September 28, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf11/P110042a.pdf
PMA Applicant: Cameron Health, Inc.
Address: 905 Calle Amanecer, Suite 300, San Clemente, CA 92673
Approval Date: September 28, 2012
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf11/P110042a.pdf
What is it? The Subcutaneous Implantable Defibrillator (S-ICD) System is a defibrillator that is implanted under the skin (subcutaneous). It provides an electric shock to the heart (defibrillation) for the treatment of an abnormally rapid heartbeat that originates from the lower chambers of the heart (ventricular tachyarrhythmias). The S-ICD System consists of:
- a titanium case containing a battery and electronic circuitry that provides defibrillation therapy and pacing at a rate of 50 beats per minute up to 30 seconds after a shock.
- a subcutaneous electrode which has a proximal and distal ring electrode on each side of a 3 inch (8 cm) defibrillation coil electrode.
- accessories include an electrode insertion tool, programmer, telemetry wand, magnet, suture sleeve, torque wrench, and memory card.
How does it work? The S-ICD (pulse generator) is implanted under the skin on the side of the chest below the arm pit. The pulse generator is connected to the electrode which is implanted under the skin from the device pocket along the rib margin to the breastbone with the use of the insertion tool.
The S-ICD monitors cardiac rhythms and delivers defibrillation when ventricular tachyarrhythmias are detected. After delivery of a shock, the S-ICD provides post-shock bradycardia pacing therapy when needed. The S-ICD is programmable as a single or dual zone device which allows the doctor to tailor the therapy for the patient.
When is it used? The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, continual (incessant) ventricular tachycardia, or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
What will it accomplish? The S-ICD System is effective in providing an electrical shock to the heart to treat life-threatening arrhythmias. In the clinical studies, the S-ICD System was shown to be capable of restoring a normal and stable rhythm thereby supporting life. The subcutaneous lead also eliminates the risks associated with implanting leads on or in the heart (transvenous leads). In addition, the System meets an unmet need for patients who are not suitable for transvenous lead placement.
When should it not be used? The S-ICD System should not be used if patients have symptomatic bradycardia, incessant ventricular tachycardia which can be terminated with anti-tachycardia pacing, and/or patients who have unipolar pacemakers.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
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