Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
implanted subcortical electrical stimulator (motor disorders)
Product Code
MRU
Device Class
Humanitarian Device Exemption
MDR Year
MDR Reports
MDR Events
2019
198
198
2020
133
133
2021
143
143
2022
169
169
2023
305
305
2024
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
180
180
Battery Problem
161
161
Connection Problem
157
157
Material Integrity Problem
150
150
Charging Problem
135
135
High impedance
127
127
Failure to Deliver Energy
97
97
Insufficient Information
92
92
Communication or Transmission Problem
79
79
Low impedance
60
60
Break
55
55
Improper or Incorrect Procedure or Method
53
53
Migration or Expulsion of Device
51
51
Inappropriate/Inadequate Shock/Stimulation
46
46
Impedance Problem
45
45
Malposition of Device
43
43
Failure to Power Up
31
31
Energy Output Problem
26
26
Failure to Interrogate
25
25
Delayed Charge Time
25
25
Patient Device Interaction Problem
25
25
Electromagnetic Compatibility Problem
22
22
Premature Discharge of Battery
21
21
Unintended Collision
20
20
Overheating of Device
18
18
Unstable
17
17
Therapeutic or Diagnostic Output Failure
15
15
Data Problem
14
14
Electromagnetic Interference
12
12
Material Frayed
12
12
Display or Visual Feedback Problem
11
11
Application Program Problem
10
10
Positioning Problem
8
8
Material Deformation
8
8
Loss of Data
7
7
No Device Output
7
7
Intermittent Continuity
6
6
Pocket Stimulation
4
4
Therapy Delivered to Incorrect Body Area
4
4
Use of Incorrect Control/Treatment Settings
3
3
Material Twisted/Bent
3
3
Operating System Becomes Nonfunctional
2
2
Activation, Positioning or Separation Problem
2
2
Audible Prompt/Feedback Problem
2
2
Unauthorized Access to Computer System
2
2
Unable to Obtain Readings
2
2
Device Difficult to Program or Calibrate
2
2
Inadequacy of Device Shape and/or Size
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Use of Device Problem
2
2
Shipping Damage or Problem
1
1
Difficult to Remove
1
1
Corroded
1
1
Degraded
1
1
Disconnection
1
1
Leak/Splash
1
1
Appropriate Term/Code Not Available
1
1
Noise, Audible
1
1
Device Dislodged or Dislocated
1
1
Environmental Compatibility Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
442
442
No Known Impact Or Consequence To Patient
132
132
Insufficient Information
123
123
Unspecified Infection
70
70
Pain
65
65
Electric Shock
49
49
Complaint, Ill-Defined
40
40
Therapeutic Response, Decreased
34
34
Dysphasia
33
33
Ambulation Difficulties
33
33
Therapeutic Effects, Unexpected
32
32
Discomfort
29
29
Unspecified Nervous System Problem
26
26
Neurological Deficit/Dysfunction
25
25
Shaking/Tremors
24
24
Muscular Rigidity
20
20
Burning Sensation
19
19
Intracranial Hemorrhage
18
18
Convulsion/Seizure
16
16
Swelling/ Edema
13
13
Cramp(s) /Muscle Spasm(s)
12
12
Cognitive Changes
12
12
Erythema
12
12
Headache
11
11
Bacterial Infection
11
11
Malaise
11
11
Neck Stiffness
10
10
Fall
10
10
Scar Tissue
10
10
Pocket Erosion
9
9
Seizures
8
8
Seroma
8
8
Purulent Discharge
8
8
Dysphagia/ Odynophagia
8
8
Erosion
7
7
Twitching
7
7
Muscle Weakness
6
6
Undesired Nerve Stimulation
5
5
Visual Impairment
5
5
Stroke/CVA
5
5
Fatigue
5
5
Fever
5
5
Hematoma
5
5
Tingling
5
5
Neck Pain
5
5
Sleep Dysfunction
5
5
Dyskinesia
4
4
Weight Changes
4
4
Hypersensitivity/Allergic reaction
4
4
Foreign Body Reaction
4
4
Wound Dehiscence
4
4
Visual Disturbances
4
4
Swelling
4
4
Inflammation
4
4
Irritation
4
4
Memory Loss/Impairment
3
3
Muscle Spasm(s)
3
3
Nausea
3
3
Staphylococcus Aureus
3
3
Abscess
3
3
Adhesion(s)
3
3
Cyst(s)
3
3
Hemorrhage/Bleeding
3
3
Fluid Discharge
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Post Operative Wound Infection
3
3
Weakness
3
3
Cramp(s)
3
3
Dizziness
3
3
Anxiety
3
3
Depression
3
3
Pallor
2
2
Mitral Valve Prolapse
2
2
Impaired Healing
2
2
Device Embedded In Tissue or Plaque
2
2
Tissue Breakdown
2
2
Movement Disorder
2
2
Paresthesia
2
2
Hemorrhage, Cerebral
2
2
Pulmonary Embolism
2
2
Dyspnea
2
2
Edema
2
2
Emotional Changes
2
2
Vomiting
2
2
Skin Erosion
2
2
Sepsis
2
2
Cellulitis
2
2
Paralysis
2
2
Paresis
2
2
Pneumonia
2
2
Pneumothorax
1
1
Nerve Damage
1
1
Hemorrhage, Intraventricular
1
1
Ischemia
1
1
Itching Sensation
1
1
Damage to Ligament(s)
1
1
Rash
1
1
Urinary Retention
1
1
Urinary Tract Infection
1
1
Vertigo
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Neuromodulation
II
May-24-2022
-
-