MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-10-19 for VENTRICLEAR? II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM? ANTIBIOTIC N-VVDC-01-ABRM manufactured by Medtronic Neurosurgery.
[57916685]
The product was unavailable for return. Therefore, an evaluation of the device performance was not possible.
Patient Sequence No: 1, Text Type: N, H10
[57916686]
It was reported to medtronic neurosurgery that a catheter broke off during removal. According to the report, the remaining portion of the catheter is inside the patient's cranium.
Patient Sequence No: 1, Text Type: D, B5
[94207998]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2016-00375 |
| MDR Report Key | 6042302 |
| Report Source | OTHER |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2011-03-09 |
| Date Added to Maude | 2016-10-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BOB SHOKOOHI |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718725 |
| 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 | VENTRICLEAR? II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM? ANTIBIOTIC |
| Generic Name | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2016-10-19 |
| Catalog Number | N-VVDC-01-ABRM |
| Lot Number | G32429 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-10-19 |