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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)
2017
2018
2019
2020
2021
2022
45
36
42
37
36
14
MDR Year
MDR Reports
MDR Events
2017
3560
3560
2018
4494
4494
2019
2818
2818
2020
2674
2674
2021
2431
2431
2022
780
780
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4195
4195
High impedance
2469
2469
Battery Problem
1571
1571
Failure to Deliver Energy
1281
1281
Device Operates Differently Than Expected
1264
1264
Charging Problem
1147
1147
Insufficient Information
1102
1102
Low impedance
1035
1035
Communication or Transmission Problem
900
900
Break
861
861
Component Misassembled
827
827
Inappropriate/Inadequate Shock/Stimulation
773
773
Unintended Collision
562
562
Energy Output Problem
532
532
Premature Discharge of Battery
471
471
Device Displays Incorrect Message
456
456
Electromagnetic Compatibility Problem
453
453
Migration or Expulsion of Device
430
430
Malposition of Device
409
409
Delayed Charge Time
380
380
Impedance Problem
361
361
Therapeutic or Diagnostic Output Failure
323
323
Low Battery
318
318
Failure to Interrogate
308
308
Improper or Incorrect Procedure or Method
278
278
Therapy Delivered to Incorrect Body Area
268
268
Connection Problem
246
246
Electromagnetic Interference
233
233
Unstable
219
219
Material Deformation
213
213
Intermittent Continuity
205
205
Shipping Damage or Problem
189
189
Patient Device Interaction Problem
147
147
Premature Elective Replacement Indicator
142
142
Display or Visual Feedback Problem
141
141
Material Integrity Problem
117
117
Data Problem
112
112
Material Twisted/Bent
107
107
No Device Output
102
102
Fracture
101
101
Overheating of Device
96
96
Pocket Stimulation
87
87
Loss of Data
83
83
Migration
81
81
Wireless Communication Problem
74
74
Unexpected Therapeutic Results
73
73
Positioning Problem
71
71
Use of Device Problem
67
67
Appropriate Term/Code Not Available
63
63
Device Contamination with Chemical or Other Material
62
62
Difficult to Open or Close
54
54
Disconnection
48
48
Incorrect, Inadequate or Imprecise Resultor Readings
46
46
Activation, Positioning or SeparationProblem
45
45
Bent
43
43
Device Or Device Fragments Location Unknown
40
40
Failure to Power Up
37
37
Human-Device Interface Problem
30
30
Environmental Compatibility Problem
27
27
Device Difficult to Program or Calibrate
27
27
No Apparent Adverse Event
24
24
Difficult to Insert
23
23
Energy Output To Patient Tissue Incorrect
23
23
Difficult to Remove
20
20
Component Missing
20
20
Defective Device
19
19
Inadequacy of Device Shape and/or Size
17
17
Unable to Obtain Readings
16
16
Application Program Problem
16
16
Device Damaged by Another Device
14
14
Improper Device Output
14
14
Peeled/Delaminated
14
14
Electro-Static Discharge
13
13
Patient-Device Incompatibility
13
13
Failure to Advance
12
12
Noise, Audible
12
12
Vibration
12
12
Shelf Life Exceeded
11
11
Material Frayed
11
11
Device Markings/Labelling Problem
11
11
Degraded
10
10
Loss of Power
9
9
Device Inoperable
9
9
Unintended Movement
9
9
Temperature Problem
8
8
Ambient Noise Problem
8
8
Application Program Freezes, Becomes Nonfunctional
8
8
Use of Incorrect Control Settings
7
7
Failure to Charge
6
6
Electrical /Electronic Property Problem
6
6
Stretched
6
6
Electrical Shorting
6
6
Operating System Becomes Nonfunctional
5
5
Mechanical Problem
5
5
Material Fragmentation
5
5
Contamination
5
5
No Display/Image
5
5
Intermittent Energy Output
5
5
Decoupling
4
4
Labelling, Instructions for Use or Training Problem
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
4800
4800
No Clinical Signs, Symptoms or Conditions
1759
1759
Unspecified Infection
1471
1472
Shaking/Tremors
1409
1410
Complaint, Ill-Defined
1389
1389
Therapeutic Effects, Unexpected
1236
1236
Therapeutic Response, Decreased
1059
1059
No Consequences Or Impact To Patient
988
988
Inadequate Pain Relief
773
773
Electric Shock
760
760
Ambulation Difficulties
750
750
Pain
497
498
Dysphasia
478
479
Cognitive Changes
447
447
Insufficient Information
421
421
Erosion
410
410
Fall
352
352
Discomfort
306
306
Muscular Rigidity
305
305
No Code Available
298
298
Undesired Nerve Stimulation
288
288
Tingling
266
266
Stroke/CVA
255
255
Intracranial Hemorrhage
220
220
Dyskinesia
207
207
Seizures
206
206
Post Operative Wound Infection
199
199
Neurological Deficit/Dysfunction
195
195
Headache
157
157
Erythema
156
156
Wound Dehiscence
145
145
Burning Sensation
133
133
Swelling
129
129
Bacterial Infection
122
122
Purulent Discharge
121
121
Confusion/ Disorientation
121
121
Pocket Erosion
118
118
Device Overstimulation of Tissue
117
117
Dizziness
114
114
Hematoma
113
113
Numbness
110
111
Anxiety
104
104
Sleep Dysfunction
95
95
Fatigue
95
95
Fluid Discharge
93
93
Scar Tissue
92
92
Staphylococcus Aureus
91
91
Loss of consciousness
89
89
Impaired Healing
87
87
Skin Erosion
86
86
Weakness
84
84
Muscle Spasm(s)
84
84
Muscle Weakness
84
84
Hemorrhage/Bleeding
79
79
Edema
78
78
Depression
77
77
Dysphagia/ Odynophagia
74
74
Death
71
71
Swelling/ Edema
70
70
Emotional Changes
68
68
Injury
65
65
Malaise
65
65
Neck Stiffness
64
64
Memory Loss/Impairment
63
63
Inflammation
62
62
Twitching
62
62
Bone Fracture(s)
61
61
Weight Changes
57
57
Paresthesia
57
57
Failure of Implant
56
56
Irritability
55
55
Hemorrhage, Cerebral
53
53
Foreign Body Reaction
53
53
Dementia
53
53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
48
48
Convulsion/Seizure
45
45
Paresis
45
45
Fever
42
42
Visual Impairment
42
42
Twiddlers Syndrome
42
42
Neck Pain
38
38
Dyspnea
37
37
Alteration In Body Temperature
35
35
Seroma
34
34
Distress
34
34
Nausea
34
34
Paralysis
33
33
Hypersensitivity/Allergic reaction
33
33
Irritation
33
33
Incontinence
33
33
Abscess
33
33
Adhesion(s)
32
32
Bruise/Contusion
32
32
High Blood Pressure/ Hypertension
31
31
Test Result
31
31
Cramp(s) /Muscle Spasm(s)
31
31
Hemorrhage, Subdural
30
30
Visual Disturbances
30
30
Tissue Breakdown
29
29
Lethargy
27
27
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
Dec-27-2021
2
Medtronic Neuromodulation
II
Nov-24-2021
3
Medtronic Neuromodulation
II
Nov-04-2021
4
Medtronic Neuromodulation
II
Apr-07-2021
5
Medtronic Neuromodulation
II
Dec-16-2020
6
Medtronic Neuromodulation
II
Aug-23-2017
7
St. Jude Medical, Inc.
II
Dec-10-2018
8
St. Jude Medical, Inc.
II
Oct-17-2017
9
St. Jude Medical, Inc.
II
Jul-07-2017
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