Brand Name | OCTRODE LEAD KIT, 90CM LENGTH |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ABBOTT MEDICAL |
6901 preston rd |
plano TX 75024 |
|
Manufacturer (Section G) |
ABBOTT MEDICAL |
6901 preston rd |
|
plano TX 75024 |
|
Manufacturer Contact |
heidi
syndergaard
|
6901 preston road |
plano, TX 75024
|
9723098000
|
|
MDR Report Key | 19057122 |
MDR Text Key | 339549142 |
Report Number | 1627487-2024-07979 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05414734401715 |
UDI-Public | (01)05414734401715(10)T00005408(17)250411 |
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/15/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 3189 |
Device Lot Number | T00005408 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/19/2024
|
Initial Date FDA Received | 04/07/2024 |
Supplement Dates Manufacturer Received | 05/07/2024
|
Supplement Dates FDA Received | 05/15/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/12/2023 |
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 |
Patient Outcome(s) |
Other;
|