Type of Device | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
Manufacturer (Section D) |
MEDTRONIC MILACA, INC. |
900 sixth avenue ne |
milaca MN 56353 3728 |
|
Manufacturer (Section G) |
MEDTRONIC MILACA, INC. |
900 sixth avenue ne |
|
milaca MN 56353 3728 |
|
Manufacturer Contact |
lisa
robertson
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635262723
|
|
MDR Report Key | 8456753 |
MDR Text Key | 140150914 |
Report Number | 2183613-2019-00051 |
Device Sequence Number | 1 |
Product Code |
DTE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K971474 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/27/2019 |
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 |
Other
|
Device Model Number | 5318 |
Device Catalogue Number | 5318 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/08/2019 |
Initial Date Manufacturer Received |
03/13/2019 |
Initial Date FDA Received | 03/27/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/17/2010 |
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 |