MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-23 for VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM UNK manufactured by Medtronic Neurologic Technologies.
[29925292]
A (b)(6) male requiring ventricular drainage. While medtronic evd system was being leveled on iv pole before the pt was being prepped for angiogram, the bag attached to the bottom of the closed system fell to the ground. This occurred without direct contact being made with the bag or the opening of the bag, but from the entire system being repositioned to be level at the eac. Diagnosis or reason for use: increased icp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057519 |
| MDR Report Key | 5187512 |
| Date Received | 2015-10-23 |
| Date of Report | 2015-08-01 |
| Date of Event | 2015-07-09 |
| Date Added to Maude | 2015-10-29 |
| 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 | VENTRICLEAR II VENTRICULAR DRAINAGE COLLECTION SYSTEM |
| Generic Name | MEDTRONIC DUET EVD |
| Product Code | PCB |
| Date Received | 2015-10-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | E144371301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROLOGIC TECHNOLOGIES |
| Manufacturer Address | 123 CREMONA DR. GOLETA CA 93117550 US 93117550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-23 |