14
DEVICE RISKS
Once the surgery is over and you have recovered, there are risks associated with
having the NeuRx DPS
®
System. The following adverse effects were seen in the
study but none were considered serious:
Table 2.
Adverse events related to the device (other than due to surgery). All were
non-serious.
Device
Adverse Event
Reported
Occurrence
(Likelihood) of
Device Adverse
Event
Notes
(About Adverse Effects,
Resolution, etc.)
infection where
electrode wire
passes through
skin (exit site)
8 out of 86
patients
(1 out of every 11
patients)
7 resolved with antibiotics.
1 resolved after the wires were adjusted
in the healthcare provider’s office.
None required removal of the wires.
discomfort from
stimulation
22 out of 86
patients
(1 out of every 4
patients)
Resolved in 20 patients.
Unresolved in 2 patients but tolerable
(the patients continued using the NeuRx
DPS
®
).
wire leading to
diaphragm –
break outside
the body
28 out of 86
patients
(about 1 out of
every 3 patients)
Affected wire does not deliver therapy
until repaired.
Requires healthcare provider
appointment to repair.
No patients had to return to surgery to
fix.
wire under skin
in chest area
(indifferent
electrode) –
break outside
the body
18 out of 86
patients
(about 1 out of
every 5 patients)
The NeuRx DPS system does not
deliver therapy until repair.
Requires healthcare provider
appointment to repair.
No patients had to return to surgery to
fix.