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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSIGHTEC LTD EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM,
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INSIGHTEC LTD EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM, Back to Search Results
Model Number 4000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Speech Disorder (4415)
Event Date 09/17/2020
Event Type  Injury  
Manufacturer Narrative
This case is still under investigation.
 
Event Description
Patient underwent essential tremor treatment that ended with complete tremor relief without adverse event.Around one month after the treatment the physician reported that the pateint had developed dysarthria.
 
Manufacturer Narrative
The retrospective analysis has not indicated any technical failures or erroneous operation of the system.Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.No new risk was recognized.
 
Event Description
Patient underwent essential tremor treatment that ended with complete tremor relief without adverse event.Around one month after the treatment the physician reported that the patient had developed dysarthria.This report is a follow up report submitted upon completion of internal investigation.
 
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Brand Name
EXABLATE 4000
Type of Device
MR GUIDED FOCUSED ULTRASOUND SYSTEM,
Manufacturer (Section D)
INSIGHTEC LTD
5 nachum heth street
tirat carmel 39120
IS  39120
MDR Report Key10823444
MDR Text Key215910452
Report Number9615058-2020-00023
Device Sequence Number1
Product Code POH
Combination Product (y/n)N
PMA/PMN Number
P1500388
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number4000
Device Catalogue NumberSYS942001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received11/11/2020
Supplement Dates Manufacturer Received10/15/2020
Supplement Dates FDA Received12/14/2020
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age68 YR
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