Brand Name | SELECTION |
Type of Device | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE |
Manufacturer (Section D) |
VITATRON MEDICAL B.V. |
p.o. box 76, 6950 |
dieren,nl |
NL |
|
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 | 4678353 |
MDR Text Key | 22061634 |
Report Number | 6000095-2015-00003 |
Device Sequence Number | 1 |
Product Code |
DXY
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | P990001 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
02/03/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 09/14/2005 |
Device Model Number | SL9000U |
Device Catalogue Number | SL9000U |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/03/2015
|
Initial Date FDA Received | 04/10/2015 |
Date Device Manufactured | 03/16/2004 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|