Brand Name | ENITRA 8 DR-T |
Type of Device | PACEMAKER |
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 | 18378518 |
MDR Text Key | 331377498 |
Report Number | 1028232-2023-06440 |
Device Sequence Number | 1 |
Product Code |
NVZ
|
Combination Product (y/n) | N |
Reporter Country Code | DE |
PMA/PMN Number | P950037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/21/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 407147 |
Device Catalogue Number | SEE MODEL NO. |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/20/2023 |
Date Device Manufactured | 07/27/2023 |
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 |
|
|