N'VISION
Received Dec 14, 2015 · Event occurred Mar 26, 2015
Report 3007566237-2015-03785 · MDR key 5293849
Device
Generic name
Legging, Compression, Non-inflatable
Manufacturer
Medtronic NeuromodulationModel number
8840Catalog number
8840
Product problems
- Human-Device Interface Problem
Patient
00054 YR
- Urinary Tract Infection
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS UNKNOWN WHAT THE PROGRAMMING ISSUE WAS THAT OCCURRED AT THE PATIENT'S REFILL. THE PATIENT HAD BEEN SEEN BY A MANUFACTURER REPRESENTATIVE ON (B)(6) 2015 BUT NO COMMUNICATION WAS GIVEN TO CHART. THE PATIENT HAD NOT SEEN THE PHYSICIAN SINCE (B)(6) 2015. THE HCP WAS UNAWARE THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI). THEY HAD NOT SEE THE PATIENT SINCE THE PATIENT STARTED GOING THROUGH WITHDRAWALS; THE PATIENT HAD CANCELLED THEIR APPOINTMENT WITH THEIR PHYSICIAN IN NOVEMBER. IT WAS UNKNOWN IF THE PATIENT WAS TREATED WITH ANTIBIOTICS. IT WAS ALSO UNKNOWN IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: PUMP. (B)(4).
Description of Event or Problem
INFORMATION RECEIVED FROM A CONSUMER PATIENT WHO WAS RECEIVING MORPHINE (CONCENTRATION AND DOSE WERE UNKNOWN). INDICATION FOR USE WAS NOTED AS NON-MALIGNANT PAIN AND RSD (REFLEX SYMPATHETIC DYSTROPHY)/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME. IT WAS REPORTED THAT THERE WAS A CHANGE IN THERAPY EFFECT. THE PATIENT HAD WITHDRAWAL FOLLOWING A REFILL THAT OCCURRED ON (B)(6) 2015. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND LATER TO THE PHYSICIAN TO HAVE THE PROGRAMMING CORRECTED. THE PATIENT HAD SYMPTOMS OF SEVERE DEHYDRATION, URINARY TRACT INFECTION (UTI) AND VOMITING FOAM. THE SYMPTOMS OCCURRED SUDDENLY. THE PATIENT WAS DEHYDRATED AND TREATED FOR A UTI IN THE ER. IT WAS STATED THAT 2 WEEKS LATER THE HEALTHCARE PROVIDER REALIZED THAT THE PATIENT'S SYMPTOMS WERE AN ISSUE ON THEIR PART AND BROUGHT THE PATIENT BACK IN. THE REFILL NURSE HAD DECREASED THE PATIENT BY 90%. REASON FOR THIS WAS MISUNDERSTANDING IN VERBAL ORDERS FROM THE HEALTHCARE PROVIDER REGARDING AMOUNT TO DECREASE. THE PATIENT OUTCOME AND DRUG CONCENTRATION/DOSE IN THE PUMP WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.