Brand Name | VITATRON C10 S SERIES |
Type of Device | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE |
Manufacturer (Section D) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud MN 1131 |
CH 1131 |
|
Manufacturer (Section G) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud MN 1131 |
CH
1131
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 9487278 |
MDR Text Key | 176646976 |
Report Number | 2182208-2019-02309 |
Device Sequence Number | 1 |
Product Code |
DXY
|
Combination Product (y/n) | N |
PMA/PMN Number | P990001 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/24/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/18/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 10/28/2011 |
Device Model Number | C10A3U |
Device Catalogue Number | C10A3U |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/19/2019 |
Date Device Manufactured | 05/12/2010 |
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 |
|
|