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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
1
1
2020
15
15
2021
202
202
2022
294
294
2023
542
542
2024
209
209
Device Problems
MDRs with this Device Problem
Events in those MDRs
Connection Problem
317
317
Material Integrity Problem
271
271
Adverse Event Without Identified Device or Use Problem
198
198
Charging Problem
157
157
Battery Problem
149
149
Insufficient Information
133
133
Inappropriate/Inadequate Shock/Stimulation
116
116
Failure to Deliver Energy
112
112
Communication or Transmission Problem
104
104
High impedance
98
98
Failure to Power Up
82
82
Failure to Interrogate
64
64
Energy Output Problem
52
52
Improper or Incorrect Procedure or Method
50
50
Low impedance
42
42
Break
38
38
Migration or Expulsion of Device
36
36
Impedance Problem
32
32
Electromagnetic Compatibility Problem
31
31
Malposition of Device
31
31
Unintended Collision
25
25
Premature Discharge of Battery
25
25
Material Frayed
24
24
Display or Visual Feedback Problem
24
24
Delayed Charge Time
21
21
Intermittent Continuity
18
18
Patient Device Interaction Problem
18
18
Unstable
17
17
No Device Output
16
16
Therapy Delivered to Incorrect Body Area
13
13
Therapeutic or Diagnostic Output Failure
13
13
Overheating of Device
11
11
Electromagnetic Interference
10
10
Application Program Problem
9
9
Loss of Data
7
7
Positioning Problem
6
6
Material Deformation
5
5
Use of Device Problem
5
5
Corroded
4
4
Operating System Becomes Nonfunctional
4
4
Data Problem
4
4
Audible Prompt/Feedback Problem
3
3
Human-Device Interface Problem
3
3
Difficult to Open or Close
3
3
Difficult to Remove
3
3
Pocket Stimulation
3
3
Mechanical Problem
2
2
Device Contamination with Chemical or Other Material
2
2
Noise, Audible
2
2
Power Problem
1
1
Unauthorized Access to Computer System
1
1
Appropriate Term/Code Not Available
1
1
Environmental Compatibility Problem
1
1
Material Twisted/Bent
1
1
Device Markings/Labelling Problem
1
1
Difficult to Insert
1
1
Degraded
1
1
Disconnection
1
1
Circuit Failure
1
1
Premature Elective Replacement Indicator
1
1
Peeled/Delaminated
1
1
Inadequacy of Device Shape and/or Size
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
770
770
Shaking/Tremors
187
187
Insufficient Information
157
157
Electric Shock
117
117
Unspecified Infection
65
65
Ambulation Difficulties
46
46
Paresthesia
44
44
Pain
44
44
Dysphasia
41
41
Erosion
18
18
Discomfort
17
17
Convulsion/Seizure
16
16
Fall
15
15
Cognitive Changes
13
13
Dizziness
12
12
Stroke/CVA
12
12
Undesired Nerve Stimulation
12
12
Numbness
12
12
Pocket Erosion
10
10
Headache
10
10
Wound Dehiscence
10
10
Intracranial Hemorrhage
9
9
Device Overstimulation of Tissue
9
9
Swelling/ Edema
9
9
Bacterial Infection
7
7
Scar Tissue
7
7
Burning Sensation
7
7
Skin Erosion
6
6
Purulent Discharge
6
6
Erythema
6
6
Muscle Weakness
6
6
Cramp(s) /Muscle Spasm(s)
6
6
Fluid Discharge
6
6
Neck Stiffness
5
5
Unspecified Tissue Injury
5
5
Hemorrhage/Bleeding
5
5
Transient Ischemic Attack
5
5
Loss of consciousness
5
5
Muscular Rigidity
4
4
Inflammation
4
4
Memory Loss/Impairment
4
4
Fatigue
4
4
Confusion/ Disorientation
4
4
Sleep Dysfunction
3
3
Post Operative Wound Infection
3
3
Foreign Body In Patient
3
3
Tissue Breakdown
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Bruise/Contusion
3
3
High Blood Pressure/ Hypertension
3
3
Hematoma
3
3
Impaired Healing
3
3
Malaise
3
3
Visual Impairment
3
3
Loss of Vision
3
3
Seroma
3
3
Paresis
2
2
Tinnitus
2
2
Inadequate Pain Relief
2
2
Irritability
2
2
Nausea
2
2
Bone Fracture(s)
2
2
Emotional Changes
2
2
Skin Inflammation/ Irritation
2
2
Suicidal Ideation
2
2
Device Embedded In Tissue or Plaque
2
2
Lethargy
2
2
Weight Changes
2
2
Choking
2
2
Respiratory Failure
2
2
Ptosis
1
1
No Known Impact Or Consequence To Patient
1
1
Shock from Patient Lead(s)
1
1
No Information
1
1
Hydrocephalus
1
1
Balance Problems
1
1
Movement Disorder
1
1
Peripheral Nervous Injury
1
1
Speech Disorder
1
1
Thrombosis/Thrombus
1
1
Unspecified Nervous System Problem
1
1
Hallucination
1
1
Decreased Appetite
1
1
Dysphagia/ Odynophagia
1
1
Dyspnea
1
1
Fever
1
1
Burn(s)
1
1
Cellulitis
1
1
Abscess
1
1
Adhesion(s)
1
1
Chest Pain
1
1
Cyst(s)
1
1
Nerve Damage
1
1
Neuropathy
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoglycemia
1
1
Incontinence
1
1
Depression
1
1
Joint Dislocation
1
1
Twitching
1
1
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