Brand Name | COROX OTW-L 85-BP |
Type of Device | LV LEAD |
Manufacturer (Section D) |
BIOTRONIK SE & CO. KG |
woermannkehre 1 |
berlin D-123 59 |
GM D-12359 |
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 5781941 |
MDR Text Key | 49149421 |
Report Number | 1028232-2016-02279 |
Device Sequence Number | 1 |
Product Code |
OJX
|
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
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
06/07/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/11/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 368346 |
Device Catalogue Number | SEE MODEL NO. |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/25/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/22/2012 |
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 |
|
|