Brand Name | TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE |
Type of Device | MESH, SURGICAL, POLYMERIC |
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 | 12091274 |
MDR Text Key | 259125508 |
Report Number | 2182208-2021-02640 |
Device Sequence Number | 1 |
Product Code |
FTL
|
UDI-Device Identifier | 00763000307882 |
UDI-Public | 00763000307882 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130943 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/30/2021 |
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 |
Lay User/Patient
|
Device Expiration Date | 03/11/2022 |
Device Model Number | CMRM6133 |
Device Catalogue Number | CMRM6133 |
Device Lot Number | R144176 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/10/2021 |
Initial Date FDA Received | 06/30/2021 |
Date Device Manufactured | 03/16/2021 |
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 | DTPB2QQ CRT-D, 6935M55 LEAD, 459888 LEAD |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 91 YR |
Patient Weight | 87 |