N'VISION
Received Dec 7, 2015 · Event occurred Nov 9, 2015
Report 3007566237-2015-03684 · MDR key 5272892
Device
Generic name
Legging, Compression, Non-inflatable
Manufacturer
Medtronic NeuromodulationModel number
8840Catalog number
8840
Product problems
- Improper or Incorrect Procedure or Method
Patient
00049 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: PUMP. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem
INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE (400MCG/ML AT 82.98) VIA AN IMPLANTED PUMP. INDICATION FOR USE WAS NOTED AS NON-MALIGNANT PAIN. IT WAS REPORTED THAT THERE WAS A DRUG RELATED PROGRAMMING ERROR. THE WRONG DRUG CONCENTRATION WAS ENTERED. AT THE PATIENT'S LAST REFILL ON (B)(6) 2015, THE HCP FILLED THE PUMP BUT DID NOT REALIZE THE CONCENTRATION HE FILLED WITH WAS 400MCG/ML CONCENTRATION. THEY LEFT THE PROGRAMMING AS 200MCG/ML AND NO BRIDGE BOLUS WAS PROGRAMMED. THE PATIENT WAS DOING FINE AND HAD NOT EXPERIENCED ANY OVERDOSE SYMPTOMS. TECHNICAL SERVICE REVIEWED THAT THE OLD DRUG HAD CLEARED THE SYSTEM ALREADY AND THAT FIXING THE SCREEN NAVIGATION FOR THE PROGRAMMING FIX AND REVIEWED SCREEN NAVIGATION FOR BRIDGE BOLUS. THE CONCENTRATION WAS ADJUSTED FROM 200CMG TO 400MCG.