LEGGING, COMPRESSION, NON-INFLATABLE
Received Feb 25, 2016
Report 3007566237-2016-01017 · MDR key 5460234
Device
Generic name
Legging, Compression, Non-inflatable
Manufacturer
Medtronic NeuromodulationModel number
NEU_UNKNOWN_PROGCatalog number
NEU_UNKNOWN_PROG
Product problems
- Human-Device Interface Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-40, SERIAL# (B)(4) IMPLANTED: (B)(6) 2013, PRODUCT TYPE: PUMP. (B)(4).
Description of Event or Problem
INFORMATION RECEIVED FROM A CONSUMER PATIENT WITH AN IMPLANTED PUMP. INDICATION FOR USE WAS NOTED AS NON-MALIGNANT PAIN AND CHRONIC LOW BACK PAIN. IT WAS REPORTED THAT THE PATIENT FELT THE MANUFACTURER SHOULD MAKE IT EASIER FOR THE PHYSICIAN TO REACH A REPRESENTATIVE WHEN THEY "NEED TO CORRECT MY PAIN PUMP WHEN NEEDED." THE LAST TIME THE PHYSICIAN WAS TOLD HE HAD TO CALL BACK LATER. EVENT DATE, DRUG(S) IN THE PUMP, CAUSE OF EVENT, CIRCUMSTANCES THAT LED TO PUMP CORRECTION, SYMPTOMS, INTERVENTIONS, AND OUTCOME WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.