Brand Name | SERENA QUAD CRT-P MRI SURESCAN |
Type of Device | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
Manufacturer (Section D) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
CH 1131 |
|
Manufacturer (Section G) |
MEDTRONIC EUROPE SARL |
route du molliau 31 |
case postale |
tolochenaz vaud 1131 |
CH
1131
|
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 10797920 |
MDR Text Key | 214990579 |
Report Number | 9614453-2020-03582 |
Device Sequence Number | 1 |
Product Code |
NKE
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P010015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/05/2020 |
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 |
Lay User/Patient
|
Device Expiration Date | 02/28/2020 |
Device Model Number | W4TR05 |
Device Catalogue Number | W4TR05 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/08/2020 |
Initial Date FDA Received | 11/06/2020 |
Date Device Manufactured | 09/06/2018 |
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 |
Treatment | 5076-52 LEAD, 4074-58 LEAD |