User's Manual

14 Cardiac Airbag Technical Manual
Patients susceptible to frequent shocks despite antiarrhythmic
medical management may develop psychological intolerance to
an ICD system that may include the following:
• Dependency
• Depression
• Fear of premature battery depletion
• Fear of shocking while conscious
• Fear that shocking capability may be lost
• Imagined shocking (phantom shock)
There may be other risks associated with this device that are
currently unforeseeable.
1.5.2 Observed Adverse Events
A clinical study of the Phylax XM involved 155 devices implanted
in 154 patients with cumulative implant duration of 1286 months
(mean implant duration 8.3 months). This clinical study was
performed with the Phylax XM and Phylax 06 ICDs, which are
earlier versions of the Cardiac Airbag ICDs. The observed
adverse events are applicable because the Cardiac Airbag ICD
is a downsized version of the Phylax XM with rate adaptive
pacing capabilities.
NOTE:
The Phylax XM ICD is an earlier generation of BIOTRONIK
devices. The Cardiac Airbag family is based upon the
Phylax XM and other BIOTRONIK ICDs (i.e., Belos VR and
Belos VR-T).
There were a total of five deaths during the course of the trial;
none of the deaths were judged by the clinical study investigator
to be device related. Heart failure was a major factor in two
deaths. The other three deaths were related to renal failure,
lung disease, and septic shock secondary to an ischemic bowel,
respectively. All five of the deaths occurred more than one
month post implant.