CATHETER, INFUSION
Received Dec 5, 2018 · Event occurred Sep 25, 2018
Report 3007566237-2018-03510 · MDR key 8132810
Device
Generic name
Catheter, Infusion
Manufacturer
Medtronic NeuromodulationModel number
NEU_UNKNOWN_CATHCatalog number
NEU_UNKNOWN_CATH
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Cerebrospinal Fluid Leakage
- Headache, Lumbar Puncture
- Cerebrospinal Fluid Leakage
- Headache, Lumbar Puncture
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY INDICATED THE PATIENT'S BASELINE WEIGHT WAS (B)(6). NO FURTHER COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY ON (B)(6) 2018 REGARDING A PATIENT RECEIVING DILAUDID VIA AN INTRATHECAL (IT) CATHETER TRIAL. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED AFTER THE IT PUMP DILAUDID TRIAL WAS PERFORMED. ON THE NEXT DAY, HE CALLED THE OFFICE STATING HE HAS LEAKING FLUID WITH A HEADACHE. THE PATIENT WAS SENT TO THE ER AND WAS ADMITTED OUTPATIENT FOR A SPINAL FLUID LEAK, WHICH WAS CONFIRMED VIA FLUOROSCOPY. A BLOOD PATCH WAS PLACED AND THE CATHETER WAS EXPLANTED/NOT REPLACED ON (B)(6) 2018. IT WAS STATED THAT THIS WAS A FAILED IT PUMP DILAUDID TRIAL. NO PRODUCT INFORMATION WAS AVAILABLE. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. THE ETIOLOGY INDICATED THE EVENT WAS UNLIKELY RELATED TO THE DEVICE OR THERAPY AND WAS POSSIBLY RELATED TO THE IMPLANT PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.