MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-12-05 for NEU_UNKNOWN_CATH manufactured by Medtronic Neuromodulation.
[129317036]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129317037]
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.
Patient Sequence No: 1, Text Type: D, B5
[134018705]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134018706]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2018-03510 |
| MDR Report Key | 8132810 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-25 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2018-12-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CATHETER, INFUSION |
| Product Code | JCY |
| Date Received | 2018-12-05 |
| Model Number | NEU_UNKNOWN_CATH |
| Catalog Number | NEU_UNKNOWN_CATH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-05 |