|
Device |
device, monitoring, intracranial pressure |
Product Code | GWM |
Regulation Number |
882.1620
|
Device Class |
2
|
Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
No Clinical Signs, Symptoms or Conditions |
1285 |
1285 |
No Known Impact Or Consequence To Patient |
1219 |
1219 |
No Information |
499 |
499 |
No Consequences Or Impact To Patient |
447 |
447 |
No Patient Involvement |
172 |
172 |
Insufficient Information |
132 |
132 |
No Code Available |
119 |
119 |
Failure of Implant |
75 |
75 |
Cerebrospinal Fluid Leakage |
72 |
72 |
Injury |
71 |
71 |
Unspecified Infection |
55 |
55 |
Death |
43 |
43 |
Device Embedded In Tissue or Plaque |
30 |
30 |
Hemorrhage/Bleeding |
21 |
21 |
Hematoma |
20 |
20 |
Unspecified Tissue Injury |
20 |
20 |
Complaint, Ill-Defined |
18 |
18 |
Foreign Body In Patient |
15 |
15 |
Headache |
15 |
15 |
Intracranial Hemorrhage |
13 |
13 |
Fever |
12 |
12 |
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available |
12 |
12 |
Patient Problem/Medical Problem |
10 |
10 |
Therapeutic Response, Decreased |
10 |
10 |
Bacterial Infection |
8 |
8 |
Neurological Deficit/Dysfunction |
8 |
8 |
Not Applicable |
8 |
8 |
Hydrocephalus |
6 |
6 |
Coma |
6 |
6 |
Brain Injury |
6 |
6 |
Vomiting |
5 |
5 |
Hernia |
4 |
4 |
Pain |
4 |
4 |
High Blood Pressure/ Hypertension |
4 |
4 |
Head Injury |
4 |
4 |
Ambulation Difficulties |
4 |
4 |
Test Result |
3 |
3 |
Edema |
3 |
3 |
Hemorrhage, Subarachnoid |
3 |
3 |
Hemorrhage, Cerebral |
3 |
3 |
Therapeutic Effects, Unexpected |
3 |
3 |
Meningitis |
3 |
3 |
Malaise |
2 |
2 |
Impaired Healing |
2 |
2 |
Post Operative Wound Infection |
2 |
2 |
Tissue Damage |
2 |
2 |
Perforation |
2 |
2 |
Staphylococcus Aureus |
2 |
2 |
Seizures |
2 |
2 |
Paralysis |
2 |
2 |
Ischemia |
2 |
2 |
Fall |
2 |
2 |
Pulmonary Embolism |
2 |
2 |
Contusion |
2 |
2 |
Aneurysm |
2 |
2 |
Cardiac Arrest |
2 |
2 |
Convulsion/Seizure |
2 |
2 |
Unspecified Nervous System Problem |
2 |
2 |
Swelling/ Edema |
2 |
2 |
Cough |
1 |
1 |
Missing Value Reason |
1 |
1 |
Pregnancy |
1 |
1 |
Autotransfusion |
1 |
1 |
Cognitive Changes |
1 |
1 |
Confusion/ Disorientation |
1 |
1 |
Vascular System (Circulation), Impaired |
1 |
1 |
Alteration In Body Temperature |
1 |
1 |
Fluid Discharge |
1 |
1 |
Air Embolism |
1 |
1 |
Burn(s) |
1 |
1 |
Fatigue |
1 |
1 |
Death, Intrauterine Fetal |
1 |
1 |
Muscle Weakness |
1 |
1 |
Necrosis |
1 |
1 |
Overdose |
1 |
1 |
Intraocular Pressure, Delayed, Uncontrolled |
1 |
1 |
Intraocular Pressure Increased |
1 |
1 |
Irritation |
1 |
1 |
Hemorrhage, Intraventricular |
1 |
1 |
Hemorrhage, Subdural |
1 |
1 |
Hyperglycemia |
1 |
1 |
Low Blood Pressure/ Hypotension |
1 |
1 |
Hypoxia |
1 |
1 |
Paresis |
1 |
1 |
Weakness |
1 |
1 |
Burning Sensation |
1 |
1 |
Twitching |
1 |
1 |
Headache, Lumbar Puncture |
1 |
1 |
Dizziness |
1 |
1 |
Swelling |
1 |
1 |
Urinary Retention |
1 |
1 |
Vasoconstriction |
1 |
1 |
Visual Impairment |
1 |
1 |
Paraplegia |
1 |
1 |
Low Oxygen Saturation |
1 |
1 |
High Oxygen Saturation |
1 |
1 |
Respiratory Failure |
1 |
1 |
Shaking/Tremors |
1 |
1 |
Loss of consciousness |
1 |
1 |
Fungal Infection |
1 |
1 |
|
|
|
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