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 2011-02-15 for VENTRICULAR CATHETER, STANDARD, BIOGLIDE 91503 manufactured by Medtronic Neurosurgery.
[1844450]
It was reported to medtronic neurosurgery that the valve was occluded.
Patient Sequence No: 1, Text Type: D, B5
[8949681]
(b)(4). The ventricular catheter passed the patency check and showed no anomalies. Although the catheter was explanted and returned, the complaint did not related to a malfunction of this part. A review of the manufacturing records showed no anomalies. No impact to pt reported. All of our catheters are 100% tested at time of manufacture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2011-00036 |
| MDR Report Key | 1999496 |
| Report Source | 01,05,06 |
| Date Received | 2011-02-15 |
| Date of Report | 2011-01-19 |
| Date of Event | 2011-01-16 |
| Date Mfgr Received | 2011-01-19 |
| Device Manufacturer Date | 2010-10-14 |
| Date Added to Maude | 2011-02-28 |
| 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 DRIVE |
| 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 | 2011-02-15 |
| Returned To Mfg | 2011-01-27 |
| Model Number | NA |
| Catalog Number | 91503 |
| Lot Number | C73134 |
| ID Number | NA |
| Device Expiration Date | 2015-07-31 |
| 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 | 2011-02-15 |