MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM 46419 manufactured by Medtronic Neurosurgery.
[108805227]
During the insertion of a lumbar drain, lumbar catheter broke off in pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077300 |
| MDR Report Key | 7525437 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-05-07 |
| Date Added to Maude | 2018-05-18 |
| 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 |
| 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 | EDM LUMBAR CATHETER, CLOSED TIP, BARIUM IMPREGNATED, 80 CM |
| Generic Name | EXTERNAL CSF DIVERSION |
| Product Code | PCB |
| Date Received | 2018-05-17 |
| Catalog Number | 46419 |
| Lot Number | E45940 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-17 |