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TPLC
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show TPLC since
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Device
implanted subcortical electrical stimulator (motor disorders)
Product Code
MRU
Device Class
Humanitarian Device Exemption
MDR Year
MDR Reports
MDR Events
2014
246
246
2015
301
301
2016
299
299
2017
163
163
2018
61
61
2019
198
198
2020
133
133
2021
143
143
2022
169
169
2023
305
305
2024
206
206
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
476
476
High impedance
298
298
Battery Problem
248
248
Device Operates Differently Than Expected
233
233
Charging Problem
232
232
Failure to Deliver Energy
217
217
Connection Problem
215
215
Material Integrity Problem
180
180
Communication or Transmission Problem
153
153
Break
135
135
Low impedance
128
128
Insufficient Information
107
107
Migration or Expulsion of Device
107
107
Inappropriate/Inadequate Shock/Stimulation
100
100
Device Displays Incorrect Message
87
87
Malposition of Device
87
87
Improper or Incorrect Procedure or Method
78
78
Impedance Problem
74
74
Low Battery
71
71
Electromagnetic Compatibility Problem
68
68
Premature Discharge of Battery
60
60
Delayed Charge Time
53
53
Unintended Collision
50
50
Intermittent Continuity
49
49
Failure to Interrogate
42
42
Failure to Power Up
39
39
Electromagnetic Interference
38
38
Energy Output Problem
35
35
Overheating of Device
33
33
Patient Device Interaction Problem
30
30
Unstable
29
29
Display or Visual Feedback Problem
22
22
Therapy Delivered to Incorrect Body Area
19
19
Material Deformation
18
18
Therapeutic or Diagnostic Output Failure
18
18
Material Frayed
18
18
Pocket Stimulation
17
17
Data Problem
14
14
Positioning Problem
14
14
Loss of Data
11
11
No Device Output
11
11
Application Program Problem
10
10
Unexpected Therapeutic Results
9
9
Device Or Device Fragments Location Unknown
7
7
Inadequacy of Device Shape and/or Size
6
6
Unable to Obtain Readings
6
6
Device Contamination with Chemical or Other Material
5
5
Electro-Static Discharge
5
5
Device Difficult to Program or Calibrate
4
4
Environmental Compatibility Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
551
551
No Known Impact Or Consequence To Patient
448
448
Complaint, Ill-Defined
245
245
Therapeutic Effects, Unexpected
210
210
Therapeutic Response, Decreased
194
194
Unspecified Infection
191
191
Neurological Deficit/Dysfunction
173
173
Insufficient Information
142
142
Pain
126
126
Electric Shock
97
97
Ambulation Difficulties
81
81
Dysphasia
74
74
Discomfort
62
62
Shaking/Tremors
55
55
Muscle Spasm(s)
45
45
Muscular Rigidity
42
42
Cognitive Changes
34
34
Intracranial Hemorrhage
32
32
Burning Sensation
31
31
Tingling
31
31
Unspecified Nervous System Problem
30
30
Undesired Nerve Stimulation
27
27
Headache
27
27
Bacterial Infection
27
27
Scar Tissue
26
26
Staphylococcus Aureus
26
26
Post Operative Wound Infection
24
24
Seizures
22
22
Seroma
21
21
Neck Stiffness
21
21
Erosion
21
21
Dysphagia/ Odynophagia
20
20
Twitching
20
20
Erythema
19
19
Malaise
18
18
Swelling
17
17
Dyskinesia
17
17
Purulent Discharge
17
17
Pocket Erosion
16
16
Stroke/CVA
16
16
Fluid Discharge
16
16
Fall
16
16
Convulsion/Seizure
16
16
Neck Pain
15
15
Fatigue
15
15
Swelling/ Edema
14
14
Wound Dehiscence
14
14
Inflammation
14
14
Skin Erosion
14
14
Test Result
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
May-24-2022
2
Medtronic Neuromodulation
I
May-01-2013
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