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TPLC
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show TPLC since
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2024
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Device
stimulator, electrical, implanted, for essential tremor
Definition
Deep Brain Stimulation for the treatment of essential tremor
Product Code
PJS
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
MDR Year
MDR Reports
MDR Events
2016
1
1
2019
2
2
2020
15
15
2021
202
202
2022
294
294
2023
542
542
2024
386
386
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
337
337
Material Integrity Problem
290
290
Adverse Event Without Identified Device or Use Problem
227
227
Charging Problem
177
177
Battery Problem
173
173
Insufficient Information
154
154
Failure to Deliver Energy
136
136
Communication or Transmission Problem
132
132
Inappropriate/Inadequate Shock/Stimulation
129
129
High impedance
117
117
Failure to Power Up
98
98
Failure to Interrogate
80
80
Energy Output Problem
66
66
Improper or Incorrect Procedure or Method
58
58
Low impedance
49
49
Break
46
46
Migration or Expulsion of Device
39
39
Impedance Problem
38
38
Malposition of Device
38
38
Electromagnetic Compatibility Problem
37
37
Display or Visual Feedback Problem
33
33
Unintended Collision
32
32
Premature Discharge of Battery
28
28
Material Frayed
26
26
Delayed Charge Time
25
25
Patient Device Interaction Problem
23
23
Unstable
20
20
Intermittent Continuity
20
20
No Device Output
18
18
Electromagnetic Interference
15
15
Therapeutic or Diagnostic Output Failure
15
15
Therapy Delivered to Incorrect Body Area
14
14
Overheating of Device
13
13
Application Program Problem
9
9
Loss of Data
9
9
Data Problem
6
6
Material Deformation
6
6
Positioning Problem
6
6
Audible Prompt/Feedback Problem
5
5
Use of Device Problem
5
5
Corroded
5
5
Operating System Becomes Nonfunctional
5
5
Difficult to Remove
3
3
Difficult to Open or Close
3
3
Noise, Audible
3
3
Human-Device Interface Problem
3
3
Pocket Stimulation
3
3
Device Contamination with Chemical or Other Material
2
2
Environmental Compatibility Problem
2
2
Mechanical Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
861
861
Shaking/Tremors
216
216
Insufficient Information
191
191
Electric Shock
130
130
Unspecified Infection
75
75
Ambulation Difficulties
52
52
Dysphasia
51
51
Paresthesia
47
47
Pain
46
46
Erosion
24
24
Discomfort
21
21
Fall
20
20
Convulsion/Seizure
18
18
Cognitive Changes
16
16
Numbness
15
15
Stroke/CVA
14
14
Undesired Nerve Stimulation
13
13
Dizziness
13
13
Wound Dehiscence
12
12
Intracranial Hemorrhage
12
12
Pocket Erosion
10
10
Headache
10
10
Swelling/ Edema
9
9
Burning Sensation
9
9
Device Overstimulation of Tissue
9
9
Bacterial Infection
8
8
Fluid Discharge
8
8
Muscle Weakness
8
8
Scar Tissue
7
7
Erythema
7
7
Skin Erosion
7
7
Purulent Discharge
7
7
Loss of consciousness
6
6
Muscular Rigidity
6
6
Cramp(s) /Muscle Spasm(s)
6
6
Hemorrhage/Bleeding
5
5
Neck Stiffness
5
5
Unspecified Tissue Injury
5
5
Confusion/ Disorientation
5
5
Transient Ischemic Attack
5
5
Fatigue
5
5
Memory Loss/Impairment
5
5
Hematoma
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Bruise/Contusion
4
4
High Blood Pressure/ Hypertension
4
4
Sleep Dysfunction
4
4
Tissue Breakdown
4
4
Inflammation
4
4
Visual Impairment
3
3
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