N'VISION
Received Dec 9, 2015 · Event occurred Nov 17, 2015
Report 2182208-2015-04113 · MDR key 5279048
Device
Generic name
Legging, Compression, Non-inflatable
Manufacturer
Medtronic, Inc.Model number
8840Catalog number
8840
Product problems
- Excess Flow or Over-Infusion
- Improper or Incorrect Procedure or Method
Patient
00057 YR
- Muscle Weakness/Atrophy
Narrative
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: PUMP. (B)(4).
Description of Event or Problem
INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING FENTANYL (1500MCG/ML AT 75MCG/DAY) AND PRIALT (25MCG/ML AND 1.2MCG/DAY). INDICATION FOR USE WAS NOTED AS POST LUMBAR LAMINECTOMY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT THERE WAS A BRIDGE BOLUS PROGRAMMING ERROR. THE DOSE WAS ENTERED INCORRECTLY. IT WAS REPORTED THAT THE PATIENT'S DAILY DOSE OF FENTANYL 75MCG/DAY WAS ENTERED IN STEAD OF PRIALT FOR THE OLD DRUG DESIRED DOSE. THE PATIENT HAD CALLED AND REPORTED FEELING SYMPTOMS OF WEAKNESS IN THE LEGS AND NAUSEA APPROXIMATELY 1.5 HOURS AFTER THEIR DRUG REFILL. THE PATIENT REPORTED THAT "IT WAS HARD TO WALK AND WHEN THEY WERE UP RIGHT THEY FELT SICK." THEY IT TO RUN FOR ABOUT AN HOUR BEFORE IT WAS CAUGHT, HE THEN STOPPED THE PUMP AND RESET IT BACK TO THE 1.2MCG/DAY. THE PATIENT WAS DOING FINE ON (B)(6) 2015.