Brand Name | VENTRICLEAR¿ II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM® ANTIBIOTIC |
Type of Device | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
Manufacturer (Section D) |
MEDTRONIC NEUROSURGERY |
125 cremona drive |
goleta CA 93117 |
|
Manufacturer (Section G) |
MEDTRONIC NEUROSURGERY |
125 cremona drive |
|
goleta CA 93117 |
|
Manufacturer Contact |
bob
shokoohi
|
125 cremona drive |
goleta, CA 93117
|
8055718725
|
|
MDR Report Key | 6042349 |
MDR Text Key | 57915497 |
Report Number | 2021898-2016-00376 |
Device Sequence Number | 1 |
Product Code |
NHC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K011812 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/19/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | N-VVDC-01-ABRM |
Device Lot Number | N6868528 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/19/2016 |
Initial Date FDA Received | 10/19/2016 |
Supplement Dates Manufacturer Received | Not provided 11/04/2016
|
Supplement Dates FDA Received | 12/02/2016 09/26/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|