Page 66 - Abbott

Table 13. Serious Adverse Events Over Part 1 and Part 2

Part 1 Part 2
Treatment Control All Patients All Patients
(270) (280) (550) (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Skin thinning of 0 0 0 0 0 0 1 1
Benign prostatic hypertrophy 0 0 1 1 1 1 0 0
Reproductive system and breast disorders 0 (0.0%) 0 1 (0.4%) 1 1 (0.2%) 1 3 (0.9%) 3
Enlarged prostate 0 0 0 0 0 0 1 1
Postmenopausal bleeding 0 0 0 0 0 0 1 1
Vaginal bleeding 0 0 0 0 0 0 1 1

Adverse Device Events

Table 14. Unanticipated or Serious Adverse Device Events Over Part 1 and Part 2
Part 1 Part 2
Treatment (270) Control (280) All Patients (550) All Patients (347)
Subjects Events Subjects Events Subjects Events Subjects Events
Unanticipated 0 (0.0%) 0 1 (0.4%) 1 1 (0.2%) 1 0 (0.0%) 0
Serious
Adverse
Device Events
Serious 2 (0.7%) 2 0 (0.0%) 0 2 (0.4%) 2 0 (0.0%) 0
Adverse
Device Events

Unanticipated Serious Adverse Device Events
There was one event during Part 1 reported as a USADE by the investigator but determined not to be serious or device system
related by the CEC which reviewed the event on 27 Jun 2009. There were no additional USADEs over Part 2 of the clinical trial.
Serious Adverse Device Events
The two SADEs that occurred during Part 1 were hemoptysis during the implant procedure and an in-situ thrombosis during the right
heart catheterization procedure. Both patients were treated and recovered without sequela. There were no additional SADEs over
Part 2 of the clinical trial.
Cleaning
 Do not submerge the system in water.
 Unplug the electronics unit prior to cleaning.
 To clean the LCD screen, make sure the electronics unit is in the power off mode. Unplug the monitor from the power source
before cleaning. Stand away from the LCD monitor and spray cleaning solution onto a clean lint free cloth. Without applying
excessive pressure, clean the screen with a slightly dampened cloth.
 To clean the antenna and electronics enclosure, wipe clean with a slightly damp cloth using soap, mild detergent, or water.
Make sure parts are dry before turning the electronics unit on.
 Follow the normal biohazard routine per hospital protocol followed for any contaminated parts.
Storage
 Store the system within the environmental limits stated in the Environmental Information section.
 Excessive vibration, impact, or rough handling may damage the system.
 Exposing the screen to rain, water, moisture or sunlight may severely damage the system.
 To avoid potential damage caused by lightning, unplug the electronics unit from any unprotected outlet during electrical storms.
User/Owner Responsibility

The Hospital Electronics System and the authorized replacement parts are designed to work as described in this manual. The user(s)
of this equipment should not use parts that have failed, exhibit excessive wear, are contaminated, or otherwise ineffective. Owner's
responsibilities:
 Replacement of components as required for safe and reliable operation
 Replacement of ineffective parts with parts supplied by the manufacturer

62