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TPLC
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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
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
453
453
High impedance
278
278
Device Operates Differently Than Expected
233
233
Battery Problem
233
233
Failure to Deliver Energy
204
204
Charging Problem
200
200
Connection Problem
171
171
Material Integrity Problem
154
154
Communication or Transmission Problem
140
140
Break
129
129
Low impedance
123
123
Migration or Expulsion of Device
106
106
Insufficient Information
100
100
Inappropriate/Inadequate Shock/Stimulation
98
98
Device Displays Incorrect Message
87
87
Malposition of Device
82
82
Low Battery
71
71
Impedance Problem
71
71
Improper or Incorrect Procedure or Method
70
70
Electromagnetic Compatibility Problem
66
66
Premature Discharge of Battery
60
60
Intermittent Continuity
46
46
Delayed Charge Time
46
46
Unintended Collision
45
45
Failure to Interrogate
38
38
Electromagnetic Interference
38
38
Energy Output Problem
33
33
Failure to Power Up
31
31
Overheating of Device
29
29
Unstable
27
27
Patient Device Interaction Problem
27
27
Therapy Delivered to Incorrect Body Area
19
19
Material Deformation
18
18
Therapeutic or Diagnostic Output Failure
17
17
Pocket Stimulation
17
17
Display or Visual Feedback Problem
15
15
Positioning Problem
14
14
Data Problem
14
14
Material Frayed
12
12
No Device Output
11
11
Loss of Data
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
Electro-Static Discharge
5
5
Use of Device Problem
4
4
Shelf Life Exceeded
4
4
Compatibility Problem
4
4
Material Twisted/Bent
4
4
Environmental Compatibility Problem
4
4
Device Contamination with Chemical or Other Material
4
4
Device Difficult to Program or Calibrate
4
4
Difficult to Remove
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Nonstandard Device
3
3
Disconnection
3
3
Use of Incorrect Control/Treatment Settings
3
3
Activation, Positioning or Separation Problem
3
3
Device Damaged by Another Device
3
3
Noise, Audible
3
3
Appropriate Term/Code Not Available
3
3
Unauthorized Access to Computer System
3
3
Unintended Movement
3
3
Audible Prompt/Feedback Problem
2
2
Operating System Becomes Nonfunctional
2
2
Shipping Damage or Problem
2
2
Bent
2
2
Fracture
2
2
Difficult to Insert
2
2
Energy Output To Patient Tissue Incorrect
2
2
Device Expiration Issue
1
1
Labelling, Instructions for Use or Training Problem
1
1
Corroded
1
1
Degraded
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Peeled/Delaminated
1
1
Material Rupture
1
1
Loss of Power
1
1
Vibration
1
1
Output Problem
1
1
No Flow
1
1
Improper Device Output
1
1
Device Dislodged or Dislocated
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
448
448
No Clinical Signs, Symptoms or Conditions
442
442
Complaint, Ill-Defined
245
245
Therapeutic Effects, Unexpected
210
210
Therapeutic Response, Decreased
194
194
Unspecified Infection
181
181
Neurological Deficit/Dysfunction
173
173
Insufficient Information
125
125
Pain
124
124
Electric Shock
95
95
Ambulation Difficulties
77
77
Dysphasia
70
70
Discomfort
57
57
Shaking/Tremors
51
51
Muscle Spasm(s)
45
45
Muscular Rigidity
40
40
Cognitive Changes
33
33
Intracranial Hemorrhage
32
32
Tingling
31
31
Burning Sensation
29
29
Bacterial Infection
27
27
Undesired Nerve Stimulation
27
27
Headache
26
26
Staphylococcus Aureus
26
26
Unspecified Nervous System Problem
26
26
Scar Tissue
25
25
Post Operative Wound Infection
23
23
Seizures
22
22
Neck Stiffness
21
21
Seroma
21
21
Dysphagia/ Odynophagia
20
20
Twitching
19
19
Malaise
18
18
Erythema
18
18
Erosion
18
18
Swelling
17
17
Dyskinesia
17
17
Convulsion/Seizure
16
16
Stroke/CVA
16
16
Purulent Discharge
16
16
Neck Pain
15
15
Fall
15
15
Pocket Erosion
15
15
Fatigue
15
15
Inflammation
14
14
Skin Erosion
14
14
Fluid Discharge
13
13
Swelling/ Edema
13
13
Wound Dehiscence
13
13
Fever
12
12
Edema
12
12
Paresis
12
12
Death
12
12
Cramp(s) /Muscle Spasm(s)
12
12
Test Result
12
12
Foreign Body Reaction
11
11
No Code Available
10
10
Hematoma
10
10
Hypersensitivity/Allergic reaction
10
10
Dizziness
10
10
Depression
9
9
Distress
9
9
Memory Loss/Impairment
9
9
Anxiety
9
9
Impaired Healing
9
9
Sleep Dysfunction
9
9
Emotional Changes
9
9
Tissue Breakdown
8
8
Confusion/ Disorientation
8
8
Visual Impairment
8
8
Hemorrhage, Cerebral
8
8
Respiratory Failure
8
8
Hemorrhage/Bleeding
8
8
Weight Changes
8
8
Loss of consciousness
7
7
Numbness
7
7
Pneumonia
7
7
Device Overstimulation of Tissue
7
7
Cramp(s)
7
7
Adhesion(s)
7
7
Muscle Weakness
7
7
Cyst(s)
6
6
Irritability
6
6
Paralysis
6
6
Abscess
6
6
Irritation
6
6
Device Embedded In Tissue or Plaque
5
5
Nausea
5
5
Loss of Range of Motion
5
5
Cellulitis
4
4
Respiratory Distress
4
4
Weakness
4
4
Vomiting
4
4
Injury
4
4
Post Traumatic Wound Infection
4
4
Itching Sensation
4
4
Visual Disturbances
4
4
Dyspnea
4
4
Tinnitus
4
4
Bruise/Contusion
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
May-24-2022
2
Medtronic Neuromodulation
I
May-01-2013
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