Brand Name | SPRINTER LEGEND RX |
Type of Device | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
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 |
toni
o'doherty
|
parkmore business park west |
galway
|
EI
|
091708734
|
|
MDR Report Key | 11064191 |
MDR Text Key | 223380359 |
Report Number | 9612164-2020-05041 |
Device Sequence Number | 1 |
Product Code |
LOX
|
Combination Product (y/n) | N |
PMA/PMN Number | P790017 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
02/12/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/23/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | SPL15010X |
Device Lot Number | 218446608 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 12/22/2020 |
Was Device Evaluated by Manufacturer? |
No Answer Provided
|
Date Device Manufactured | 09/09/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|