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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
10
MDR Year
MDR Reports
MDR Events
2019
2818
2818
2020
2674
2674
2021
2426
2426
2022
2257
2257
2023
3495
3495
2024
1802
1802
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3620
3620
High impedance
2101
2101
Connection Problem
1902
1902
Battery Problem
1700
1700
Material Integrity Problem
1624
1624
Insufficient Information
1290
1290
Charging Problem
1166
1166
Failure to Deliver Energy
1032
1032
Low impedance
765
765
Communication or Transmission Problem
730
730
Break
657
657
Inappropriate/Inadequate Shock/Stimulation
565
565
Failure to Power Up
548
548
Energy Output Problem
437
437
Impedance Problem
376
376
Therapeutic or Diagnostic Output Failure
363
363
Electromagnetic Compatibility Problem
337
337
Migration or Expulsion of Device
333
333
Failure to Interrogate
317
317
Premature Discharge of Battery
317
317
Malposition of Device
310
310
Improper or Incorrect Procedure or Method
299
299
Unintended Collision
296
296
Delayed Charge Time
244
244
Unstable
183
183
Display or Visual Feedback Problem
168
168
Material Deformation
165
165
Patient Device Interaction Problem
161
161
Material Twisted/Bent
158
158
Material Frayed
148
148
Wireless Communication Problem
137
137
Fracture
136
136
Electromagnetic Interference
134
134
Overheating of Device
130
130
Shipping Damage or Problem
121
121
Data Problem
120
120
Migration
117
117
Therapy Delivered to Incorrect Body Area
115
115
Intermittent Continuity
111
111
Loss of Data
100
100
Positioning Problem
81
81
Use of Device Problem
76
76
Unexpected Therapeutic Results
71
71
Difficult to Open or Close
68
68
Application Program Problem
59
59
No Device Output
57
57
No Apparent Adverse Event
49
49
Disconnection
44
44
Pocket Stimulation
42
42
Operating System Becomes Nonfunctional
41
41
Device Contamination with Chemical or Other Material
39
39
Human-Device Interface Problem
33
33
Premature Elective Replacement Indicator
30
30
Difficult to Remove
28
28
Difficult to Insert
27
27
Activation, Positioning or Separation Problem
27
27
Device Markings/Labelling Problem
27
27
Component Missing
26
26
Incorrect, Inadequate or Imprecise Result or Readings
22
22
Noise, Audible
22
22
Device Difficult to Program or Calibrate
20
20
Mechanical Problem
20
20
Vibration
18
18
Unintended Movement
17
17
Failure to Advance
16
16
Unable to Obtain Readings
16
16
Environmental Compatibility Problem
14
14
Inadequacy of Device Shape and/or Size
13
13
Defective Device
13
13
Degraded
12
12
Electro-Static Discharge
11
11
Appropriate Term/Code Not Available
11
11
Contamination
10
10
Device Damaged by Another Device
9
9
Audible Prompt/Feedback Problem
9
9
Corroded
8
8
Material Fragmentation
8
8
Peeled/Delaminated
8
8
Unsealed Device Packaging
7
7
Intermittent Energy Output
6
6
Temperature Problem
6
6
Manufacturing, Packaging or Shipping Problem
5
5
Application Program Freezes, Becomes Nonfunctional
5
5
Unexpected Shutdown
5
5
Device Displays Incorrect Message
5
5
Ambient Noise Problem
5
5
Use of Incorrect Control/Treatment Settings
4
4
Failure to Charge
4
4
Mechanical Jam
4
4
Unauthorized Access to Computer System
4
4
Device Contaminated During Manufacture or Shipping
4
4
Power Problem
3
3
Component Misassembled
3
3
Material Split, Cut or Torn
3
3
Failure to Disconnect
3
3
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
6098
6098
No Known Impact Or Consequence To Patient
1927
1927
Unspecified Infection
1353
1353
Inadequate Pain Relief
1016
1016
Insufficient Information
964
964
Shaking/Tremors
917
917
Electric Shock
548
548
Ambulation Difficulties
493
493
Complaint, Ill-Defined
459
459
Therapeutic Response, Decreased
407
407
Erosion
391
391
Pain
326
326
Therapeutic Effects, Unexpected
311
311
Cognitive Changes
289
289
Dysphasia
276
276
Fall
252
252
Discomfort
229
229
Failure of Implant
225
225
Post Operative Wound Infection
207
207
Muscular Rigidity
204
204
Intracranial Hemorrhage
202
202
No Code Available
192
192
Movement Disorder
179
179
Wound Dehiscence
165
165
Swelling/ Edema
147
147
Undesired Nerve Stimulation
138
138
Bacterial Infection
133
133
Stroke/CVA
132
132
No Consequences Or Impact To Patient
131
131
Headache
125
125
Burning Sensation
116
116
Purulent Discharge
115
115
Dyskinesia
110
110
Erythema
108
108
Convulsion/Seizure
106
106
Pocket Erosion
103
103
Paresthesia
101
101
Hematoma
98
98
Tingling
92
92
Confusion/ Disorientation
88
88
Fluid Discharge
84
84
Skin Erosion
78
78
Device Overstimulation of Tissue
78
78
Muscle Weakness
73
73
Impaired Healing
71
71
Seizures
69
69
Scar Tissue
68
68
Loss of consciousness
68
68
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
68
68
Numbness
65
65
Hemorrhage/Bleeding
61
61
Sleep Dysfunction
60
60
Fatigue
58
58
Implant Pain
56
56
Unspecified Nervous System Problem
55
55
Swelling
55
55
Inflammation
54
54
Cramp(s) /Muscle Spasm(s)
54
54
Dizziness
52
52
Neurological Deficit/Dysfunction
52
52
Depression
48
48
Emotional Changes
46
46
Dysphagia/ Odynophagia
46
46
Anxiety
42
42
Malaise
37
37
Bone Fracture(s)
37
37
Neck Stiffness
35
35
Weight Changes
35
35
Twiddlers Syndrome
33
33
Visual Impairment
33
33
Paresis
32
32
Memory Loss/Impairment
32
32
Fever
32
32
Twitching
32
32
Edema
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
Suicidal Ideation
24
24
Hemorrhage, Cerebral
24
24
Neck Pain
23
23
Hallucination
22
22
Unspecified Tissue Injury
22
22
High Blood Pressure/ Hypertension
20
20
Visual Disturbances
19
19
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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