PROMETRA® II PROGRAMMABLE PUMP
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System Organ Class
Preferred Term
N (%)
Injury, Poisoning and Procedural
Complications
Procedural Pain
37 (34)
Post Lumbar Puncture Syndrome
9 (8)
Wound Secretion
9 (8)
Seroma
4 (4)
Wound Dehiscence
3 (3)
Musculoskeletal and Connective
Tissue Disorders
Back Pain
2 (2)
Pain in Extremity
2 (2)
Nervous System Disorders
Headache
8 (7)
Dizziness
3 (3)
Intracranial Hypotension
2 (2)
Skin and Subcutaneous Tissue
Disorders
Dermatitis Contact
5 (5)
Pruritus
2 (2)
Scab
2 (2)
Surgical and Medical Procedures
Surgery
1
10 (9)
1
Surgery to replace or revise intrathecal catheter
Adverse Events with incidence of 1% or less. Tinnitus, Abdominal Pain, Constipation,
Oral Mucosal
Blistering, Catheter Site Edema, Implant Site Bruising, Implant Site Effusion, Implant Site
Hypersensitivity, Implant Site Irritation, Implant Site Necrosis, Edema Peripheral, Hypersensitivity,
Extradural Abscess, Implant Site Cellulitis, Spinal Infection Viral, Excoriation, Hip Fracture
2
, Procedural
Nausea, Balance Disorder, Burning Sensation, Diplegia, Hypoaesthesia, Neuropathy Peripheral, Tremor,
Dyspnoea, Respiratory Depression, Ecchymosis, Rash, Haematoma.
2
Event occurred while patient was being treated with a drug other than Infumorph via Prometra System
Equipment
•
Prometra II Programmable Pump
•
Intrathecal Catheter
•
Tunneler
•
Prometra Programmer (Not Sterile)
The following items may be needed and are not provided:
•
Sterile Programmer Sleeve
•
Sterile preservative-free 0.9% saline
•
Infumorph solution (infusate) for refill, not to exceed 20 mL
Pump Operation
Programmable Features
The Prometra Programmer uses telemetry to exchange information with the pump. This information
includes the following:
•
Date and Time
•
Current Prescription
•
Patient Identification
•
Drug Name and Concentration
•
Flow Mode, Drug Dose and Delivery Rate
