Model Number 37602 |
Device Problems
High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
|
Patient Problems
Tingling (2171); Complaint, Ill-Defined (2331); Electric Shock (2554)
|
Event Type
Injury
|
Event Description
|
It was reported a few days following the patient¿s replacement surgery, they noticed a tingling on their chest as well as up and down their right arm.It was noted, the lead was in the left ventral intermediate nucleus (vim).The patient¿s right hand and arm would kind of go into a ¿flailing mode¿ and it would affect their motor coordination.It was described as intermittent shocking symptoms.The old implantable neurostimulator (ins) was at the exact settings but at a lower amplitude.An electrode impedance test was performed and c0 showed high at 2360 ohms.It was noted the intermittent shocking occurred a few times a day and they could reproduce it if the patient pushed on the ins.When the patient pressed on the ins the impedance test was redone and c0 showed 1217 and the tingling sensation faded.It was noted the issue appeared with 0.It was further reported on the day of report in the operating room they tried to re-enact the impedances but it showed normal the entire time.It was noted the doctor went ahead and replaced the ins on the day of report.
|
|
Event Description
|
Additional information reported there was a greater than 50% symptom reduction for the patient.The ins was confirmed to be involved with the event.Impedances were checked pre- and post-operation in july.The cause was not determined and it is unknown if it is device-related.The patient recovered without permanent impairment.
|
|
Manufacturer Narrative
|
Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# v157349, implanted: 2008 (b)(6); product type lead product id 7482a66, serial# (b)(4), implanted: 2008 (b)(6); product type extension (b)(4).
|
|
Manufacturer Narrative
|
Analysis of the neurostimulator, serial #(b)(4), found no anomaly.It was connected to a known good extension and lead and the impedances were measured to be good on every electrode pair.It also functioned properly through other tests.
|
|
Manufacturer Narrative
|
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|