Brand Name | INTICA 7 VR-T DX DF-1 PROMRI |
Type of Device | ICD |
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 | 19210043 |
MDR Text Key | 341479965 |
Report Number | 1028232-2024-02382 |
Device Sequence Number | 1 |
Product Code |
LWS
|
Combination Product (y/n) | N |
Reporter Country Code | DE |
PMA/PMN Number | P050023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
04/29/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/29/2024 |
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 | 404633 |
Device Catalogue Number | SEE MODEL NO. |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/29/2024 |
Date Device Manufactured | 03/14/2019 |
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) |
Hospitalization;
Hospitalization;
|