Brand Name | NA |
Type of Device | PROGRAMMER, PACEMAKER |
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 |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7414952 |
MDR Text Key | 105245225 |
Report Number | 2182208-2018-00453 |
Device Sequence Number | 1 |
Product Code |
KRG
|
UDI-Device Identifier | 10681490142653 |
UDI-Public | 10681490142653 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P890003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/24/2018 |
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 | 10/21/2022 |
Device Model Number | 6177 |
Device Catalogue Number | 6177 |
Device Lot Number | D0349 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/12/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/18/2018 |
Initial Date FDA Received | 04/10/2018 |
Supplement Dates Manufacturer Received | 05/01/2018
|
Supplement Dates FDA Received | 05/24/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/21/2017 |
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 |
|
|