IMD_Warnigns

AngelMed Guardian IMD©

Model AMSG3

Indications

The AngelMed Guardian System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The Guardian System is indicated for use in patients who have had prior acute coronary syndrome (ACS) events and who remain at high risk for recurrent ACS events.
The Guardian System is indicated as an adjunct to patient recognized symptoms. The Guardian System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events.
A Guardian System alert is a more accurate predictor of ACS events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events (false positives) when compared to patient recognized symptoms alone.
In the absence of symptoms, the Guardian System may identify asymptomatic ACS events and prompt the patient to seek medical attention.

Contraindications

The AngelMed Guardian System should not be implanted in:

  1. Patients with cognitive impairment that would prevent recognition of alarms
  2. Patients who cannot feel the vibration from the IMD
  3. Patients with implanted pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices
  4. Patients where a pacemaker lead cannot be placed safely

Warnings & Precautions

  • The IMD is intended for subcutaneous implantation in a left pectoral pocket. Do not implant the IMD in any other location.
  • For reliable data transmission, implant the device within 2 in
    (5 cm) of the surface of the skin.
  • Implantation should not be attempted if venous access is inadequate to support placement of the endocardial lead in the apex of the right ventricle.
  • The AngelMed Guardian system has not been evaluated for implantation in patients with non-sinus cardiac rhythm, 2nd and 3rd degree atrioventricular blocks, or right or left bundle-branch blocks.

Therapies where electrical current passes through the body may interfere with IMD operation and cause it to alarm if there is no heart problem, or not alarm if there is a problem. At your discretion, you may advise your patients to visit your office so that you can temporarily disable IMD alarms if they need to undergo such therapy.
Alarms are temporarily disabled from the Programmer’s Edit Alarm Configuration window. See the AngelMed Guardian Programmer Application User’s Manual for more information.

The AngelMed Guardian system is protected against most sources of electromagnetic interference (EMI). However, sources of strong EMI can damage the IMD and EXD and interfere with the wireless communication between them. See the AngelMed Guardian User’s Manual for further information. 

Patients should be advised to not engage in contact sports like football since the EXD, IMD, or lead may get damaged. Also, they should be encouraged to consult with you before doing strenuous or repetitive upper-body exercise like weight lifting or softball.

Potential Adverse Effects

  • Air embolism
  • Bleeding
  • Cardiac perforation
  • Cardiac dissection
  • Damage to the vessel at the catheter insertion site
  • Device failure resulting in removal or replacement
  • Erosion
  • False positive ST shift alarm –  device alarms when there is no clinically relevant ST shift
  • Formation of fibrotic tissue, local tissue reaction
  • Fluid accumulation
  • Induced ventricular ectopy
  • Infection
  • Keloid formation
  • Lead migration/ dislodgment
  • Myocardial irritability
  • Nausea and vomiting
  • Palpitations
  • Pericardial rub
  • Procedure related, random component failure
  • Stroke (brain attack) from a clot being dislodged by the catheter
  • Thrombosis
  • Valve damage (particularly in fragile hearts)
  • Venous perforation
  • Ventricular fibrillation
  • Allergic reaction
  • Body rejection phenomena including local tissue rejection
  • Cardiac tamponade
  • Chronic nerve damage
  • Death
  • Endocarditis
  • Excessive fibrotic tissue growth
  • Extrusion
  • False negative ST shift alarm risk of the device not detecting all ST shift events
  • Formation of hematomas or cysts
  • Ischemia
  • Lead abrasion and discontinuity
  • Loss of sensing due to dislodgement or mechanical malfunction of the lead
  • Myocardial damage
  • Pain in shoulder or arm
  • Pericardial effusion
  • Pneumothorax
  • Shunting current or insulating myocardium during defibrillation with internal or external paddles
  • Thromboemboli
  • Vascular complications, which may require vessel repair
  • Venous occlusion
  • Vein wall rupture