CATHETER, INFUSION
Report
- Report Number
- 3007566237-2018-03510
- Event Type
- Injury
- Date Received
- December 5, 2018
- Date of Event
- September 25, 2018
- Report Date
- December 25, 2018
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- JCY
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 973056 | CATHETER, INFUSION | JCY | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_CATH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |