Brand Name | ACHIEVE MAPPING CATHETER |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Manufacturer (Section D) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
tijuana,bc 22570 |
MX 22570 |
|
Manufacturer (Section G) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
|
tijuana,bc 22570 |
MX
22570
|
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 8148706 |
MDR Text Key | 129839597 |
Report Number | 9612164-2018-03543 |
Device Sequence Number | 1 |
Product Code |
DRF
|
Combination Product (y/n) | N |
Reporter Country Code | AG |
PMA/PMN Number | K102588 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/10/2018 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 990063-020 |
Device Catalogue Number | 990063-020 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/27/2018
|
Initial Date FDA Received | 12/10/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 | 4FC12 SHEATH |
Patient Outcome(s) |
Death;
Required Intervention;
|
Patient Age | 51 YR |
Patient Weight | 90 |
|
|