MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-02-20 for VENTRICLEAR COOK CATHETER EVD 5 PK NVVDC01ABRM manufactured by Medtronic Neurosurgery.
[5360611]
It was reported to medtronic neurosurgery that a patient had a ventricular drain placed on (b)(6) 2014 due to a brain hemorrhage. According to the report, the patient developed a fever on (b)(6) 2014. On (b)(6) 2014, the patient's csf tested positive for serratia. It was reported that the patient's ventricular drain was removed on (b)(6) 2014 and the patient was discharged from the hospital to comfort care on (b)(6) 2015. According to the report, the patient died due to complications of meningitis and a brain bleed on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[12893473]
The product was unavailable for return. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records was not possible as no lot number was provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94193846]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2015-00064 |
| MDR Report Key | 4529939 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-20 |
| Date of Event | 2014-12-25 |
| Date Mfgr Received | 2015-01-20 |
| Date Added to Maude | 2015-02-20 |
| 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 | JEFFREY HENDERSON |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8055718445 |
| 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 COOK CATHETER EVD 5 PK |
| Generic Name | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2015-02-20 |
| Catalog Number | NVVDC01ABRM |
| Lot Number | UNKNOWN |
| 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 | 2015-02-20 |