Pages: [1]   Go Down
Print
Author Topic: Lithium  (Read 1419 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« on: January 16, 2016, 04:08:00 AM »

Model Number 102
Event Date 08/31/2012
Event Type Malfunction
Event Description
It was reported by the patient's mother that her son had been very lethargic recently and had been experiencing an increase in his seizures. She also reported that her son's white blood count was low and he was also diagnosed with lithium poisoning two months prior. Attempts for additional information are in progress.

Manufacturer Narrative

Event Description
Additional information was received that the patient was seen by a new neurologist who referred the patient for a generator replaced but did not have the reason. When asked it was said that it may be related to the may have been due to the "lithium battery" or the seizures but they had no information about the seizures or lithium poisoning only that they referred the patient to a neurosurgeon for a generator replacement good faith attempts with the patient's former neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2851687
« Last Edit: March 19, 2016, 01:06:06 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63465


« Reply #1 on: March 19, 2016, 01:06:36 AM »

Model Number 102
Event Date 01/10/2011
Event Type Injury
Event Description
It was initially inquired by a vns patient's speech therapist whether the patient's lithium and vns could be interacting and causing his imbalance. According to the reporter, the patient walks with a walker because of the imbalance. Follow-up from the patient's current psychiatrist revealed that she did not have a vns programming system to check the patient's device. The patient was subsequently referred to another psychiatrist who could perform vns dosing. The patient's wife also called to inquire about the components of the vns generator batteries. She was concerned that the lithium battery may be leaking and causing the patient's symptoms as she indicated that the patient has "a reaction" to lithium. It was explained to the patient's wife that a battery leak of this sort was unlikely and had not been found in the past. The patient visited a new psychiatrist who performs vns dosing, and further information from the new psychiatrist was obtained. She indicated that she had programmed the patient to 0 ma/1 hz/130 microsec/7 sec/0. 2 min and 0 ma/7 sec/130 microsec in order to see if the vns was causing any of the patient's problems, and that the end-of-service indicator currently said "no". She also indicated that the patient had been set to 0. 25 ma/25 hz/250 microsec/30 sec/5 min and 0 ma/60 sec/500 microsec previously, and the patient had been at these settings "for a long time". Consequently, the physician did not want to perform diagnostic testing as it would run at 1 ma, which the patient may not tolerate. The new psychiatrist did note that the patient no longer took lithium, and it was explained to the physician that the patient's generator was not leaking lithium as it could still be interrogated. The physician also stated that disabling the patient's device was not done to preclude a serious injury, and it was unknown if the patient's device would be kept disabled. Good faith attempts to date to gain more information on the patient's ambulatory difficulties have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1987924
Logged
Pages: [1]   Go Up
Print
Jump to: