MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-10 for EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT 27303 manufactured by Medtronic Neurosurgery.
[188295185]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188295186]
It was reported that the patient had a cerebrospinal fluid leak after pituitary tumor surgery; therefore, the patient was implanted with a lumbar drain on (b)(6) 2020. During the surgery, a fracture occurred during the puncture and placement of the tube. The device was replaced, and the surgery was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2020-00009 |
| MDR Report Key | 9575297 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-04-18 |
| Date Added to Maude | 2020-01-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT |
| Generic Name | DEVICE, MONITORING, INTRACRANIAL PRESSURE |
| Product Code | GWM |
| Date Received | 2020-01-10 |
| Model Number | 27303 |
| Catalog Number | 27303 |
| Lot Number | 217248114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |