Brand Name | PERCUTANEOUS LEAD INTRODUCER |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street ne |
mounds view MN 55112 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
8200 coral sea street ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 13058426 |
MDR Text Key | 282605234 |
Report Number | 2182208-2021-05036 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 00643169646179 |
UDI-Public | 00643169646179 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K911236 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/22/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/22/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/29/2023 |
Device Model Number | 6209-S1 |
Device Catalogue Number | 6209-S1 |
Device Lot Number | GB6263280 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/16/2021 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/20/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/01/2021 |
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 |
|
|