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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)
2019
2020
2021
2022
2023
2024
42
37
36
34
31
7
MDR Year
MDR Reports
MDR Events
2019
2818
2818
2020
2674
2674
2021
2426
2426
2022
2257
2257
2023
3495
3495
2024
885
885
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3542
3542
High impedance
2058
2058
Battery Problem
1661
1661
Connection Problem
1437
1437
Material Integrity Problem
1252
1252
Insufficient Information
1248
1248
Charging Problem
1051
1051
Failure to Deliver Energy
1016
1016
Low impedance
754
754
Communication or Transmission Problem
711
711
Break
643
643
Inappropriate/Inadequate Shock/Stimulation
557
557
Energy Output Problem
433
433
Failure to Power Up
376
376
Impedance Problem
367
367
Therapeutic or Diagnostic Output Failure
360
360
Electromagnetic Compatibility Problem
332
332
Migration or Expulsion of Device
325
325
Premature Discharge of Battery
315
315
Malposition of Device
307
307
Failure to Interrogate
304
304
Improper or Incorrect Procedure or Method
294
294
Unintended Collision
293
293
Delayed Charge Time
241
241
Unstable
178
178
Material Deformation
162
162
Patient Device Interaction Problem
159
159
Material Twisted/Bent
156
156
Display or Visual Feedback Problem
136
136
Fracture
135
135
Electromagnetic Interference
134
134
Wireless Communication Problem
134
134
Shipping Damage or Problem
121
121
Data Problem
119
119
Migration
117
117
Therapy Delivered to Incorrect Body Area
114
114
Intermittent Continuity
110
110
Material Frayed
106
106
Overheating of Device
105
105
Loss of Data
100
100
Positioning Problem
81
81
Use of Device Problem
76
76
Unexpected Therapeutic Results
70
70
Difficult to Open or Close
67
67
No Device Output
57
57
Application Program Problem
56
56
No Apparent Adverse Event
49
49
Disconnection
44
44
Pocket Stimulation
42
42
Device Contamination with Chemical or Other Material
39
39
Operating System Becomes Nonfunctional
33
33
Premature Elective Replacement Indicator
30
30
Human-Device Interface Problem
29
29
Difficult to Remove
28
28
Device Markings/Labelling Problem
27
27
Component Missing
26
26
Difficult to Insert
26
26
Activation, Positioning or Separation Problem
24
24
Noise, Audible
21
21
Device Difficult to Program or Calibrate
20
20
Incorrect, Inadequate or Imprecise Result or Readings
19
19
Vibration
17
17
Failure to Advance
16
16
Unintended Movement
15
15
Environmental Compatibility Problem
14
14
Defective Device
13
13
Unable to Obtain Readings
13
13
Inadequacy of Device Shape and/or Size
13
13
Mechanical Problem
13
13
Degraded
12
12
Appropriate Term/Code Not Available
11
11
Electro-Static Discharge
10
10
Device Damaged by Another Device
9
9
Peeled/Delaminated
8
8
Corroded
8
8
Material Fragmentation
8
8
Unsealed Device Packaging
7
7
Temperature Problem
6
6
Audible Prompt/Feedback Problem
6
6
Intermittent Energy Output
6
6
Application Program Freezes, Becomes Nonfunctional
5
5
Unexpected Shutdown
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Contamination
5
5
Device Displays Incorrect Message
5
5
Ambient Noise Problem
5
5
Unauthorized Access to Computer System
4
4
Device Contaminated During Manufacture or Shipping
4
4
Mechanical Jam
3
3
Component Misassembled
3
3
Material Split, Cut or Torn
3
3
Failure to Disconnect
3
3
Failure to Charge
3
3
Use of Incorrect Control/Treatment Settings
2
2
No Display/Image
2
2
Separation Failure
2
2
Patient-Device Incompatibility
2
2
Structural Problem
2
2
Premature End-of-Life Indicator
2
2
Off-Label Use
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5273
5273
No Known Impact Or Consequence To Patient
1927
1927
Unspecified Infection
1340
1340
Inadequate Pain Relief
1015
1015
Insufficient Information
941
941
Shaking/Tremors
904
904
Electric Shock
541
541
Ambulation Difficulties
486
486
Complaint, Ill-Defined
459
459
Therapeutic Response, Decreased
407
407
Erosion
384
384
Pain
323
323
Therapeutic Effects, Unexpected
311
311
Cognitive Changes
288
288
Dysphasia
271
271
Fall
251
251
Discomfort
222
222
Failure of Implant
210
210
Muscular Rigidity
203
203
Intracranial Hemorrhage
200
200
Post Operative Wound Infection
198
198
No Code Available
192
192
Wound Dehiscence
163
163
Movement Disorder
160
160
Swelling/ Edema
143
143
Undesired Nerve Stimulation
137
137
No Consequences Or Impact To Patient
131
131
Stroke/CVA
130
130
Bacterial Infection
127
127
Headache
125
125
Purulent Discharge
114
114
Burning Sensation
109
109
Erythema
108
108
Dyskinesia
107
107
Convulsion/Seizure
105
105
Pocket Erosion
102
102
Paresthesia
98
98
Hematoma
97
97
Tingling
92
92
Confusion/ Disorientation
87
87
Fluid Discharge
81
81
Skin Erosion
78
78
Device Overstimulation of Tissue
76
76
Muscle Weakness
72
72
Impaired Healing
71
71
Seizures
69
69
Loss of consciousness
68
68
Scar Tissue
66
66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
65
65
Numbness
63
63
Hemorrhage/Bleeding
60
60
Sleep Dysfunction
58
58
Fatigue
57
57
Implant Pain
56
56
Swelling
55
55
Cramp(s) /Muscle Spasm(s)
54
54
Unspecified Nervous System Problem
54
54
Inflammation
53
53
Neurological Deficit/Dysfunction
52
52
Dizziness
51
51
Depression
48
48
Emotional Changes
45
45
Dysphagia/ Odynophagia
44
44
Anxiety
41
41
Bone Fracture(s)
37
37
Malaise
36
36
Weight Changes
35
35
Twiddlers Syndrome
33
33
Neck Stiffness
33
33
Twitching
32
32
Memory Loss/Impairment
32
32
Visual Impairment
32
32
Paresis
31
31
Edema
31
31
Fever
31
31
Hypersensitivity/Allergic reaction
30
30
Nausea
30
30
Paralysis
30
30
Foreign Body Reaction
29
29
Adhesion(s)
29
29
Dyspnea
27
27
Death
27
27
Twiddlers Syndrome
27
27
Seroma
27
27
Weakness
27
27
Irritability
26
26
Staphylococcus Aureus
26
26
Muscle Spasm(s)
26
26
Abscess
26
26
Lethargy
25
25
Hemorrhage, Cerebral
24
24
Neck Pain
23
23
Suicidal Ideation
22
22
Hallucination
21
21
Unspecified Tissue Injury
21
21
High Blood Pressure/ Hypertension
20
20
Visual Disturbances
18
18
Device Embedded In Tissue or Plaque
18
18
Speech Disorder
17
17
Tissue Breakdown
17
17
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Nov-03-2023
2
Medtronic Neuromodulation
II
Oct-18-2023
3
Medtronic Neuromodulation
II
Apr-19-2023
4
Medtronic Neuromodulation
II
May-24-2022
5
Medtronic Neuromodulation
II
Dec-27-2021
6
Medtronic Neuromodulation
II
Nov-24-2021
7
Medtronic Neuromodulation
II
Nov-04-2021
8
Medtronic Neuromodulation
II
Apr-07-2021
9
Medtronic Neuromodulation
II
Dec-16-2020
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