Brand Name | SOLOTRAK KR 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 | 8950098 |
MDR Text Key | 156118831 |
Report Number | 2182208-2019-01587 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 00681490142939 |
UDI-Public | 00681490142939 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K911236 |
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 |
Report Date |
08/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/22/2021 |
Device Model Number | 6207BTK-1 |
Device Catalogue Number | 6207BTK-1 |
Device Lot Number | W4681493 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/13/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/01/2019 |
Initial Date FDA Received | 08/30/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/10/2019 |
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 |
|
|