ASCENDA
Received Feb 4, 2016 · Event occurred Mar 31, 2013
Report 3007566237-2016-00584 · MDR key 5411736
Device
Generic name
Legging, Compression, Non-inflatable
Manufacturer
Medtronic NeuromodulationModel number
8780Catalog number
8780
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Meningitis
- Meningitis
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. THE PUMP WAS DELIVERING SALINE. IT WAS REPORTED THAT THE PUMP SYSTEM WAS REMOVED A FEW DAYS AFTER SURGERY DUE TO SPINAL MENINGITIS. PATIENT GOT SPINAL MENINGITIS A FEW DAYS AFTER SURGERY, THEN HAD TO HAVE IT TAKEN OUT IMMEDIATELY AS IT WAS CONTAMINATED. THE PATIENT DOES NOT HAVE ANY DEVICE AND NEVER GOT ANY MEDICATION THROUGH IT JUST SALINE. THE PATIENT WAS EXCITED ABOUT GETTING IT BUT WAS TOLD IT WOULD ONLY BE A LAST RESORT PROCEDURE. THERE WERE NO TROUBLESHOOTING OR INTERVENTIONS REPORTED. IN ADDITION, THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4).