Brand Name | FIRMAP¿ CATHETER 50MM, US EDM |
Type of Device | ELECTRODE RECORDING CATHETER |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
5050 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL |
5050 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
stephanie
o' sullivan
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 8925315 |
MDR Text Key | 155343876 |
Report Number | 3005334138-2019-00456 |
Device Sequence Number | 1 |
Product Code |
MTD
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K130827 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/23/2019 |
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 |
No Information
|
Device Expiration Date | 04/30/2020 |
Device Model Number | AR064050 |
Device Catalogue Number | AR064050 |
Device Lot Number | TPR041117 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/18/2019 |
Initial Date FDA Received | 08/23/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/02/2017 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 58 YR |
Patient Weight | 98 |