Model Number 304-20 |
Device Problem
High impedance (1291)
|
Patient Problems
Seizures (2063); No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/12/2017 |
Event Type
malfunction
|
Event Description
|
It was reported the patient had high impedance several times during surgery.The generator was isolated and tested with the test resistor pin and found to be working.The lead pin was re-inserted to verify adequate insertion and the lead was changed out.The patient's nerve was irrigated to make sure it had not dried and the size of the lead was checked to verify it was the appropriate size for the patient.It was later explained the surgery decided to close the patient and have the neurologist check the patient in a month to see if the high impedance was still present.The lead impedance reportedly showed >10,000 ohms during surgery.The device history records for both the lead and the generator were reviewed and each device had passed all testing prior to distribution.No additional relevant information has been received to date.
|
|
Manufacturer Narrative
|
Describe event or problem; corrected data: mfr.Report # 1644487-2017-03763 houses the report of the lead which was initially used but discarded during the surgery, prior to implanting the lead which is captured within this mfr.Report." was inadvertently not reported on the initial mfr.Report.
|
|
Event Description
|
Mfr.Report # 1644487-2017-03763 houses the report of the lead which was initially used but discarded during the surgery, prior to implanting the lead which is captured within this mfr.Report.No additional relevant information has been received to date.
|
|
Event Description
|
In 2020, the patient was referred for potential revision due to high impedance.The patient had one seizures recently.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.
|
|
Event Description
|
It was reported that the patient's generator was replaced due to battery depletion and high impedance on (b)(6) 2020.High impedance was still present post-generator replacement.The new generator was unable to verify heart rate which is expected on a system with high impedance.No further relevant information has been received to date.
|
|
Event Description
|
During a periodic review of the programming history database, it was noted that the patient's device was disabled (b)(6) 2020.No further relevant information has been received to date.
|
|
Event Description
|
It was reported that the patient's battery was low.
|
|
Search Alerts/Recalls
|