Brand Name | ILIVIA 7 HF-T QP DF4 IS4 PROMRI |
Type of Device | CRT-D |
Manufacturer (Section D) |
BIOTRONIK SE & CO. KG |
woermannkehre 1 |
berlin 12359 |
DE 12359 |
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 18331032 |
MDR Text Key | 330802533 |
Report Number | 1028232-2023-06356 |
Device Sequence Number | 1 |
Product Code |
NIK
|
UDI-Device Identifier | 04035479142087 |
UDI-Public | (01)04035479142087(17)210930 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P050023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/14/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/14/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2021 |
Device Model Number | 404621 |
Device Catalogue Number | SEE MODEL NO. |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/19/2023 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/11/2023 |
Date Device Manufactured | 03/09/2020 |
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) |
Hospitalization;
|
Patient Age | 75 YR |
Patient Sex | Male |