Brand Name | SENTUS PROMRI OTW QP L-85/49 |
Type of Device | LV LEAD |
Manufacturer (Section D) |
BIOTRONIK SE & CO. KG |
woermannkehre 1 |
berlin 12359 |
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 16281322 |
MDR Text Key | 308630659 |
Report Number | 1028232-2023-00571 |
Device Sequence Number | 1 |
Product Code |
OJX
|
UDI-Device Identifier | 04035479148959 |
UDI-Public | (01)04035479148959(17)200930 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P070008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2020 |
Device Model Number | 408719 |
Device Catalogue Number | SEE MODEL NO. |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/26/2023 |
Initial Date FDA Received | 02/01/2023 |
Supplement Dates Manufacturer Received | 02/02/2023
|
Supplement Dates FDA Received | 02/06/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/26/2018 |
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 | 50 YR |