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 |
|
Manufacturer (Section G) |
SYNCARDIA SYSTEMS, LLC |
1992 e. silverlake road |
|
tucson, az |
|
Manufacturer Contact |
kerri
hensley
|
1992 e. silverlake road |
tucson, az
|
5451234120
|
|
MDR Report Key | 10310687 |
MDR Text Key | 199976970 |
Report Number | 3003761017-2020-00163 |
Device Sequence Number | 1 |
Product Code |
LOZ
|
UDI-Device Identifier | 00858000003008 |
UDI-Public | (01)00858000003008 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P030011 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
07/21/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/22/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2022 |
Device Model Number | 500101-001 |
Device Catalogue Number | 500101 |
Device Lot Number | 119816 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/20/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2019 |
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 | 54 YR |