|
|
| 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 |
1331 |
1331 |
| 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 |
152 |
152 |
| No Code Available |
119 |
119 |
| Failure of Implant |
75 |
75 |
| Cerebrospinal Fluid Leakage |
72 |
72 |
| Injury |
71 |
71 |
| Unspecified Infection |
56 |
56 |
| Death |
43 |
43 |
| Device Embedded In Tissue or Plaque |
30 |
30 |
| Unspecified Tissue Injury |
21 |
21 |
| Hematoma |
21 |
21 |
| Hemorrhage/Bleeding |
21 |
21 |
| Complaint, Ill-Defined |
18 |
18 |
| Headache |
15 |
15 |
| Foreign Body In Patient |
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 |
| Brain Injury |
6 |
6 |
| Coma |
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 |
| Hemorrhage, Cerebral |
3 |
3 |
| Edema |
3 |
3 |
| Hemorrhage, Subarachnoid |
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 |
| Ischemia |
2 |
2 |
| Muscle Weakness |
2 |
2 |
| Paralysis |
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 |
| Paresis |
1 |
1 |
| Overdose |
1 |
1 |
| Necrosis |
1 |
1 |
| Low Blood Pressure/ Hypotension |
1 |
1 |
| Hypoxia |
1 |
1 |
| Hemorrhage, Subdural |
1 |
1 |
| Hyperglycemia |
1 |
1 |
| Hemorrhage, Intraventricular |
1 |
1 |
| Intraocular Pressure, Delayed, Uncontrolled |
1 |
1 |
| Intraocular Pressure Increased |
1 |
1 |
| Irritation |
1 |
1 |
| Swelling |
1 |
1 |
| Urinary Retention |
1 |
1 |
| Vasoconstriction |
1 |
1 |
| Visual Impairment |
1 |
1 |
| Discomfort |
1 |
1 |
| Weakness |
1 |
1 |
| Burning Sensation |
1 |
1 |
| Twitching |
1 |
1 |
| Headache, Lumbar Puncture |
1 |
1 |
| Dizziness |
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 |
|
|
|
|
