Brand Name | UNKNOWN STRATA VALVE/SHUNT |
Type of Device | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS |
Manufacturer (Section D) |
MEDTRONIC NEUROSURGERY |
125 cremona drive |
goleta CA 93117 |
|
Manufacturer (Section G) |
MEDTRONIC NEUROSURGERY |
125 cremona drive |
|
goleta CA 93117 |
|
Manufacturer Contact |
stacy
ruemping
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635260594
|
|
MDR Report Key | 8458081 |
MDR Text Key | 140081729 |
Report Number | 2021898-2019-00134 |
Device Sequence Number | 1 |
Product Code |
JXG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/29/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN-S |
Device Catalogue Number | UNKNOWN-S |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/26/2019 |
Initial Date FDA Received | 03/27/2019 |
Supplement Dates Manufacturer Received | 04/15/2019
|
Supplement Dates FDA Received | 04/29/2019
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|