Brand Name | SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) |
Type of Device | BIVENTRICULAR REPLACEMENT DEVICE |
Manufacturer (Section D) |
SYNCARDIA SYSTEMS, LLC. |
1992 e. silverlake road |
tucson AZ 85713 |
|
Manufacturer (Section G) |
SYNCARDIA SYSTEMS, LLC. |
1992 e. silverlake road |
|
tucson AZ 85713 |
|
Manufacturer Contact |
aaron
meier
|
1992 e. silverlake road |
tucson, AZ 85713
|
|
MDR Report Key | 17005583 |
MDR Text Key | 315963992 |
Report Number | 3003761017-2023-00079 |
Device Sequence Number | 1 |
Product Code |
LOZ
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | P030011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/25/2023 |
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 Catalogue Number | P/N 500101 |
Device Lot Number | 126280 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/15/2023
|
Initial Date FDA Received | 05/25/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2022 |
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 |
Patient Outcome(s) |
Death;
|
Patient Age | 67 YR |
Patient Sex | Male |