IPG MFG SWITZERLAND SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
|
Back to Search Results |
|
Model Number 7426 |
Device Problems
Electromagnetic Interference (1194); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)
|
Patient Problems
Fall (1848); Therapeutic Effects, Unexpected (2099)
|
Event Date 10/12/2014 |
Event Type
Injury
|
Event Description
|
It was reported that ¿every time¿ the patient¿s hippocampal implantable neurostimulator (ins) was turned on, the patient ¿had seizures.¿ the patient had reportedly been seizure free ¿for a long time,¿ however, the patient¿s seizures had recently ¿come on strong after being exposed to electromagnetic interference¿ (emi).The emi (at a security screener gate) was reported to have turned the patient¿s ins on.This event had occurred on (b)(6) 2014.The ins was turned off following the event.The patient was ¿seizure free for four weeks until (b)(6) 2014 when they had seizures again and fell.¿ as a result, the patient ¿had to go to the hospital for assistance.¿ it was noted that at that time ¿they thought the patient was having a stroke.¿ the patient ¿hadn¿t had another event since (b)(6) 2014 when the hospital reprogrammed the implant to be at 0 volts, so if it came back on accidentally, it would come back on at 0 volts.¿ the patient reportedly experienced ¿anxiety around emi because of the event¿ and ¿wanted the implant removed for peace of mind.¿ additional information has been requested; a supplemental report will be filed if additional information is received.
|
|
Manufacturer Narrative
|
Please note, this device was used for an off label indication.(b)(4).
|
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information reported the patient¿s device was turned off some time laterafter implant because they could not get it to work right.The patient noted their ¿pre-implant seizures worsened¿ with the device and the deep brain stimulation (dbs) ¿made symptoms worse.¿ it was stated that ¿no improvement¿ was received following reprogramming.The ins remained implanted, but off at the time of follow-up.The patient also reported they could not wear a seatbelt over the side of the ins.
|
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|