MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-03-01 for UNKNOWN VENTRICLEAR CATHETER UNKNOWN-C manufactured by Medtronic Neurosurgery.
[101339338]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101339339]
It was reported an external ventricular drain (evd) was placed in a pediatric intensive care unit patient. During removal of the evd one week later, a 0. 5 cm portion of the distal tip fractured. The patient was taken to surgery four days later and the fragment was retrieved successfully. There was no information available regarding what events or activities contributed or could have contributed to the fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00105 |
| MDR Report Key | 7308754 |
| Report Source | OTHER |
| Date Received | 2018-03-01 |
| Date of Report | 2018-03-01 |
| Date of Event | 2017-10-01 |
| Date Mfgr Received | 2018-02-06 |
| Date Added to Maude | 2018-03-01 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| 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 | UNKNOWN VENTRICLEAR CATHETER |
| Generic Name | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2018-03-01 |
| Model Number | UNKNOWN-C |
| Catalog Number | UNKNOWN-C |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2018-03-01 |