MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-03-21 for VENTRICULAR CATHETER, STANDARD, BIOGLIDE 91503 manufactured by Medtronic Neurosurgery.
[1918756]
It was reported to medtronic neurosurgery that a pt's symptoms did not improve after valve implantation. According to the report, a contrast study was performed and the valve's performance level was changed to 0. 5, however, there was no improvement in the pt's symptoms. The pt's condition improved after revision surgery.
Patient Sequence No: 1, Text Type: D, B5
[9091984]
(b)(4). A 10 cm of catheter was returned sutured to the valve inlet. The catheter was evaluated and met specifications. The conditions of the complaint could not be duplicated by laboratory personnel. A review of the mfg records showed no anomalies. No impact to pt reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2011-00058 |
| MDR Report Key | 2030872 |
| Report Source | 01,05,06 |
| Date Received | 2011-03-21 |
| Date of Report | 2011-02-26 |
| Date Mfgr Received | 2011-02-26 |
| Device Manufacturer Date | 2010-07-26 |
| Date Added to Maude | 2011-03-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059681546 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DR. |
| 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 | VENTRICULAR CATHETER, STANDARD, BIOGLIDE |
| Product Code | JXZ |
| Date Received | 2011-03-21 |
| Returned To Mfg | 2011-03-03 |
| Model Number | NA |
| Catalog Number | 91503 |
| Lot Number | C71626 |
| ID Number | NA |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DR. GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-03-21 |