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TPLC
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Device
stimulator, electrical, implanted, for parkinsonian tremor
Product Code
MHY
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
36
42
37
36
34
22
MDR Year
MDR Reports
MDR Events
2018
4494
4494
2019
2818
2818
2020
2674
2674
2021
2426
2426
2022
2257
2257
2023
1586
1586
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4110
4110
High impedance
2480
2480
Battery Problem
1809
1809
Insufficient Information
1345
1345
Failure to Deliver Energy
1198
1198
Charging Problem
1012
1012
Low impedance
917
917
Communication or Transmission Problem
859
859
Component Misassembled
827
827
Break
793
793
Inappropriate/Inadequate Shock/Stimulation
679
679
Energy Output Problem
585
585
Unintended Collision
452
452
Electromagnetic Compatibility Problem
425
425
Premature Discharge of Battery
420
420
Device Operates Differently Than Expected
412
412
Migration or Expulsion of Device
402
402
Therapeutic or Diagnostic Output Failure
388
388
Impedance Problem
381
381
Malposition of Device
376
376
Failure to Interrogate
324
324
Delayed Charge Time
320
320
Improper or Incorrect Procedure or Method
318
318
Connection Problem
234
234
Unstable
206
206
Material Deformation
194
194
Electromagnetic Interference
190
190
Therapy Delivered to Incorrect Body Area
179
179
Patient Device Interaction Problem
173
173
Device Displays Incorrect Message
167
167
Shipping Damage or Problem
157
157
Material Twisted/Bent
150
150
Fracture
140
140
Intermittent Continuity
133
133
Data Problem
133
133
Wireless Communication Problem
121
121
Migration
115
115
Display or Visual Feedback Problem
108
108
Premature Elective Replacement Indicator
106
106
Overheating of Device
105
105
Low Battery
102
102
Loss of Data
99
99
Material Integrity Problem
91
91
Positioning Problem
85
85
No Device Output
84
84
Use of Device Problem
80
80
Unexpected Therapeutic Results
79
79
Difficult to Open or Close
69
69
Pocket Stimulation
65
65
Appropriate Term/Code Not Available
61
61
Disconnection
50
50
Device Contamination with Chemical or Other Material
49
49
Application Program Problem
46
46
No Apparent Adverse Event
43
43
Incorrect, Inadequate or Imprecise Result or Readings
41
41
Failure to Power Up
39
39
Activation, Positioning or Separation Problem
39
39
Human-Device Interface Problem
33
33
Difficult to Insert
30
30
Difficult to Remove
29
29
Component Missing
29
29
Device Markings/Labelling Problem
27
27
Device Difficult to Program or Calibrate
24
24
Environmental Compatibility Problem
20
20
Defective Device
19
19
Device Or Device Fragments Location Unknown
17
17
Failure to Advance
16
16
Inadequacy of Device Shape and/or Size
15
15
Unable to Obtain Readings
14
14
Electro-Static Discharge
14
14
Patient-Device Incompatibility
13
13
Peeled/Delaminated
13
13
Bent
13
13
Material Frayed
12
12
Device Damaged by Another Device
12
12
Unintended Movement
11
11
Noise, Audible
11
11
Degraded
10
10
Vibration
10
10
Loss of Power
9
9
Use of Incorrect Control/Treatment Settings
8
8
Energy Output To Patient Tissue Incorrect
8
8
Temperature Problem
8
8
Operating System Becomes Nonfunctional
8
8
Application Program Freezes, Becomes Nonfunctional
8
8
Improper Device Output
7
7
Electrical Shorting
6
6
Electrical /Electronic Property Problem
6
6
Material Fragmentation
6
6
Failure to Charge
6
6
Intermittent Energy Output
6
6
Unexpected Shutdown
5
5
No Display/Image
5
5
Mechanical Problem
5
5
Ambient Noise Problem
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Power Problem
4
4
Unauthorized Access to Computer System
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Device Contaminated During Manufacture or Shipping
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
3423
3423
No Clinical Signs, Symptoms or Conditions
3165
3165
Unspecified Infection
1466
1467
Shaking/Tremors
1204
1205
Inadequate Pain Relief
1069
1069
No Consequences Or Impact To Patient
988
988
Complaint, Ill-Defined
893
893
Insufficient Information
789
789
Therapeutic Response, Decreased
750
750
Therapeutic Effects, Unexpected
698
698
Electric Shock
660
660
Ambulation Difficulties
651
651
Erosion
435
435
Pain
427
428
Dysphasia
391
392
Cognitive Changes
387
387
Fall
328
328
No Code Available
291
291
Discomfort
281
281
Muscular Rigidity
263
263
Intracranial Hemorrhage
229
229
Undesired Nerve Stimulation
210
210
Stroke/CVA
207
207
Post Operative Wound Infection
203
203
Tingling
179
179
Wound Dehiscence
176
176
Dyskinesia
163
163
Headache
157
157
Bacterial Infection
144
144
Seizures
144
144
Failure of Implant
140
140
Erythema
139
139
Neurological Deficit/Dysfunction
131
131
Burning Sensation
129
129
Pocket Erosion
126
126
Swelling/ Edema
126
126
Confusion/ Disorientation
121
121
Purulent Discharge
120
120
Hematoma
112
112
Swelling
102
102
Device Overstimulation of Tissue
96
96
Dizziness
96
96
Numbness
92
93
Skin Erosion
92
92
Impaired Healing
91
91
Fluid Discharge
90
90
Convulsion/Seizure
86
86
Paresthesia
85
85
Muscle Weakness
85
85
Loss of consciousness
82
82
Sleep Dysfunction
80
80
Scar Tissue
80
80
Hemorrhage/Bleeding
76
76
Movement Disorder
74
74
Depression
72
72
Anxiety
70
70
Emotional Changes
69
69
Fatigue
69
69
Inflammation
65
65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
63
63
Staphylococcus Aureus
60
60
Weakness
60
60
Edema
58
58
Muscle Spasm(s)
57
57
Neck Stiffness
57
57
Dysphagia/ Odynophagia
55
55
Bone Fracture(s)
53
53
Weight Changes
50
50
Malaise
50
50
Twitching
45
45
Memory Loss/Impairment
45
45
Cramp(s) /Muscle Spasm(s)
44
44
Unspecified Nervous System Problem
42
42
Injury
41
41
Implant Pain
41
41
Irritability
40
40
Visual Impairment
40
40
Hemorrhage, Cerebral
39
39
Death
39
39
Dyspnea
38
38
Foreign Body Reaction
38
38
Paresis
38
38
Fever
36
36
Twiddlers Syndrome
36
36
Neck Pain
36
36
Abscess
34
34
Nausea
33
33
Hypersensitivity/Allergic reaction
32
32
Seroma
32
32
Adhesion(s)
32
32
Paralysis
30
30
High Blood Pressure/ Hypertension
28
28
Alteration In Body Temperature
26
26
Twiddlers Syndrome
26
26
Device Embedded In Tissue or Plaque
25
25
Hemorrhage, Subdural
24
24
Bruise/Contusion
23
23
Irritation
23
23
Visual Disturbances
23
23
Tissue Breakdown
22
22
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Apr-19-2023
2
Medtronic Neuromodulation
II
May-24-2022
3
Medtronic Neuromodulation
II
Dec-27-2021
4
Medtronic Neuromodulation
II
Nov-24-2021
5
Medtronic Neuromodulation
II
Nov-04-2021
6
Medtronic Neuromodulation
II
Apr-07-2021
7
Medtronic Neuromodulation
II
Dec-16-2020
8
St. Jude Medical, Inc.
II
Dec-10-2018
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