15
Device
Adverse Event
Reported
Occurrence
(Likelihood) of
Device Adverse
Event
Notes
(About Adverse Effects,
Resolution, etc.)
wire under skin
in chest area
(indifferent
electrode)
came out of the
body
6 out of 86
patients
(in about 1 out of
every 14 patients)
No patients had to return to surgery to
fix.
Fix involves reinserting the wire under
the skin in the healthcare provider’s
office under topical anesthetic.
Patient may temporarily use an
alternate part (the backup indifferent
electrode interconnect) until an
appointment can be made for the
healthcare provider to reinsert the wire
under the skin.
broken NeuRx
®
EPG
(stimulator)
6 out of 86
patients
(in about 1 out of
every 14 patients)
No NeuRx DPS
®
therapy can occur
without a working NeuRx
®
EPG. A
replacement NeuRx
®
EPG can be shipped
to the patient.
broken patient
cables
4 out of 86
patients
(in about 1 out of
every 22 patients)
No NeuRx DPS
®
therapy can occur
without a working patient cable. Two
cables are provided with each kit. The
patient cables are meant to be disposable.
More replacement cables can be shipped
to patient.
pain where
electrode wire
passes through
skin (exit site)
3 out of 86
patients
(about 1 out of
every 29 patients)
All 3 cases were “mild” pain.
One case resolved in 12 days. One
case resolved in 5 days.
One case did not resolve. The
healthcare provider’s report described
said that pain was “really mild and
occurs rarely”.
skin irritation or
inflammation
5 out of 86
patients
(about 1 out of
every 17 patients)
All 5 cases were “mild” in severity.
All cases resolved within a month and a
half (except one case in which the time
to resolve was unknown). The average
time to resolve was 18 days. The
longest known time to resolve was 43
days.