Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
MAUDE Adverse Event Report:; SPINAL CORD STIMULATOR
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
; SPINAL CORD STIMULATOR
Back to Search Results
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems
Nerve Damage (1979); Device Overstimulation of Tissue (1991); Pain (1994)
Event Date
10/16/2017
Event Type
Injury
Event Description
A report was received via social media that the patient was experiencing pain, spinal nerve damage and repeated electric shocks.The patient underwent an explant procedure.No further information could be obtained.
Search Alerts/Recalls
New Search
|
Submit an Adverse Event Report
Brand Name
NI
Type of Device
SPINAL CORD STIMULATOR
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key
6998269
MDR Text Key
90929345
Report Number
3006630150-2017-04411
Device Sequence Number
1
Product Code
LGW
Combination Product (y/n)
N
PMA/PMN Number
030017
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Manufacturer
Source Type
consumer,other
Reporter Occupation
Patient
Type of Report
Initial
Report Date
10/16/2017
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
Lay User/Patient
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
No
Initial Date Manufacturer Received
10/16/2017
Initial Date FDA Received
11/02/2017
Was Device Evaluated by Manufacturer?
Device Not Returned to Manufacturer
Is the Device Single Use?
Yes
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
Initial
Patient Sequence Number
1
Patient Outcome(s)
Required Intervention;
-
-