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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)
2020
2021
2022
2023
2024
2025
37
36
34
31
47
16
MDR Year
MDR Reports
MDR Events
2020
2674
2674
2021
2426
2426
2022
2258
2258
2023
3495
3495
2024
4379
4379
2025
1424
1424
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3599
3599
High impedance
2275
2275
Connection Problem
2267
2267
Battery Problem
2015
2015
Material Integrity Problem
1970
1970
Insufficient Information
1306
1306
Charging Problem
1229
1229
Failure to Deliver Energy
1065
1065
Communication or Transmission Problem
777
777
Low impedance
704
704
Failure to Power Up
691
691
Break
683
683
Inappropriate/Inadequate Shock/Stimulation
515
515
Impedance Problem
444
444
Failure to Interrogate
381
381
Therapeutic or Diagnostic Output Failure
373
373
Energy Output Problem
343
343
Migration or Expulsion of Device
338
338
Display or Visual Feedback Problem
332
332
Electromagnetic Compatibility Problem
328
328
Improper or Incorrect Procedure or Method
314
314
Malposition of Device
263
263
Premature Discharge of Battery
255
255
Unintended Collision
246
246
Delayed Charge Time
241
241
Material Twisted/Bent
211
211
Unstable
189
189
Material Deformation
181
181
Fracture
170
170
Wireless Communication Problem
167
167
Migration
166
166
Material Frayed
165
165
Overheating of Device
150
150
Patient Device Interaction Problem
145
145
Data Problem
131
131
Electromagnetic Interference
116
116
Intermittent Continuity
115
115
Use of Device Problem
108
108
Operating System Becomes Nonfunctional
104
104
Unexpected Therapeutic Results
101
101
Loss of Data
99
99
Therapy Delivered to Incorrect Body Area
96
96
Difficult to Open or Close
93
93
No Apparent Adverse Event
82
82
Unintended Application Program Shut Down
81
81
Positioning Problem
75
75
Shipping Damage or Problem
75
75
Application Program Problem
68
68
No Device Output
51
51
Difficult to Remove
44
44
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8319
8319
Insufficient Information
1312
1312
Unspecified Infection
1300
1300
Inadequate Pain Relief
941
941
No Known Impact Or Consequence To Patient
856
856
Shaking/Tremors
807
807
Failure of Implant
732
732
Movement Disorder
649
649
Electric Shock
487
487
Ambulation Difficulties
448
448
Erosion
403
403
Pain
331
331
Dysphasia
242
242
Cognitive Changes
242
242
Discomfort
240
240
Fall
234
234
Post Operative Wound Infection
224
224
Intracranial Hemorrhage
215
215
Swelling/ Edema
198
198
Complaint, Ill-Defined
192
192
Therapeutic Response, Decreased
190
190
Muscular Rigidity
181
181
Wound Dehiscence
181
181
Bacterial Infection
146
146
Undesired Nerve Stimulation
137
137
Burning Sensation
131
131
Convulsion/Seizure
130
130
Therapeutic Effects, Unexpected
130
130
Paresthesia
126
126
Headache
119
119
Purulent Discharge
118
118
Erythema
114
114
Dyskinesia
110
110
No Code Available
104
104
Implant Pain
104
104
Stroke/CVA
99
99
Hematoma
96
96
Pocket Erosion
94
94
Confusion/ Disorientation
93
93
Fluid Discharge
90
90
Muscle Weakness
85
85
Scar Tissue
80
80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
76
76
Skin Erosion
76
76
Unspecified Nervous System Problem
74
74
Device Overstimulation of Tissue
73
73
Loss of consciousness
73
73
No Consequences Or Impact To Patient
73
73
Impaired Healing
71
71
Cramp(s) /Muscle Spasm(s)
70
70
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical
II
Jul-25-2024
2
Abbott Medical
II
Jul-03-2024
3
Medtronic Neuromodulation
II
Oct-23-2024
4
Medtronic Neuromodulation
II
Jul-24-2024
5
Medtronic Neuromodulation
II
Nov-03-2023
6
Medtronic Neuromodulation
II
Oct-18-2023
7
Medtronic Neuromodulation
II
Apr-19-2023
8
Medtronic Neuromodulation
II
May-24-2022
9
Medtronic Neuromodulation
II
Dec-27-2021
10
Medtronic Neuromodulation
II
Nov-24-2021
11
Medtronic Neuromodulation
II
Nov-04-2021
12
Medtronic Neuromodulation
II
Apr-07-2021
13
Medtronic Neuromodulation
II
Dec-16-2020
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