Brand Name | CARELINK |
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 | 7702268 |
MDR Text Key | 114727118 |
Report Number | 2182208-2018-01314 |
Device Sequence Number | 1 |
Product Code |
KRG
|
UDI-Device Identifier | 00613994581594 |
UDI-Public | 00613994581594 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P890003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/03/2018 |
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 |
Other
|
Device Model Number | 2090 |
Device Catalogue Number | 2090 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/12/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/11/2018 |
Initial Date FDA Received | 07/19/2018 |
Supplement Dates Manufacturer Received | 08/08/2018
|
Supplement Dates FDA Received | 10/03/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/12/2003 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|