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 CARDIAC RHYTHM HEART FAILURE |
8200 coral sea st ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 5120073 |
MDR Text Key | 27481448 |
Report Number | 2183613-2015-00921 |
Device Sequence Number | 1 |
Product Code |
DTE
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K971474 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Followup |
Report Date |
07/20/2015 |
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 Model Number | 5318 |
Device Catalogue Number | 5318 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/20/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/01/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/09/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |