MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for MEDTRONIC EDM LUMBAR DRAINAGE KIT W/120ML GRADUATED manufactured by Medtronic Neurosurgery.
[128246697]
Lumber drain placed without output in the first hour; found a portion of the drain broke off in patient; removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081456 |
| MDR Report Key | 8089475 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-10-30 |
| Date Added to Maude | 2018-11-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDTRONIC EDM LUMBAR DRAINAGE KIT W/120ML GRADUATED |
| Generic Name | EXTERNAL CEREBROSPINAL FLUID DIVERSION |
| Product Code | PCB |
| Date Received | 2018-11-19 |
| Model Number | EDM |
| Lot Number | 210491239 |
| Device Expiration Date | 2018-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-19 |