Brand Name | OCTRODE LEAD KIT, 90CM LENGTH |
Type of Device | SCS PERCUTANEOUS 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 | 18843207 |
MDR Text Key | 336957867 |
Report Number | 1627487-2024-07377 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05414734401715 |
UDI-Public | 05414734401715 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/07/2024 |
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 Expiration Date | 04/26/2019 |
Device Model Number | 3189 |
Device Lot Number | 5951880 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/15/2024
|
Initial Date FDA Received | 03/05/2024 |
Supplement Dates Manufacturer Received | 03/19/2024
|
Supplement Dates FDA Received | 04/07/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/26/2017 |
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 |
Treatment | SCS ANCHOR (2); SCS IPG (1) |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |
Patient Weight | 79 KG |