Brand Name | ZUMA ZM 5F GUIDE CATHETER |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
MEDTRONIC, INC |
37a cherry hill dr |
danvers MA 01923 |
|
Manufacturer (Section G) |
MEDTRONIC, INC |
37a cherry hill dr |
|
danvers MA 01923 |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 5572929 |
MDR Text Key | 42500205 |
Report Number | 1220452-2016-00027 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | K990707 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/16/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/13/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/30/2014 |
Device Catalogue Number | ZM5JR40 |
Device Lot Number | 0006431124 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/16/2016 |
Date Device Manufactured | 08/30/2012 |
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 Age | 00066 YR |
Patient Weight | 85 |
|
|