Brand Name | ACHIEVE ADVANCE MAPPING CATHETER |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT |
Manufacturer (Section D) |
MEDTRONIC, INC. |
8200 coral sea street ne |
mounds view MN 55112 |
|
Manufacturer (Section G) |
MEDTRONIC, INC. |
8200 coral sea street ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 12006009 |
MDR Text Key | 256456584 |
Report Number | 2182208-2021-02420 |
Device Sequence Number | 1 |
Product Code |
DRF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162892 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/15/2021 |
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 | 2ACH20 |
Device Catalogue Number | 2ACH20 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/25/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/08/2021
|
Initial Date FDA Received | 06/15/2021 |
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 | AFAPRO28 BALLOON CATHETER |