Brand Name | OCTRODE LEAD KIT, 60CM LENGTH |
Type of Device | SCS LEAD |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer Contact |
martha
livingston
|
6901 preston road |
plano, TX 75024
|
9725264871
|
|
MDR Report Key | 7315840 |
MDR Text Key | 101571986 |
Report Number | 3006705815-2018-00404 |
Device Sequence Number | 1 |
Product Code |
GZB
|
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 |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/10/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/17/2019 |
Device Model Number | 3186 |
Device Lot Number | A000039085 |
Other Device ID Number | 05415067017246 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/20/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/07/2018
|
Initial Date FDA Received | 03/06/2018 |
Supplement Dates Manufacturer Received | 03/19/2018
|
Supplement Dates FDA Received | 04/10/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/17/2017 |
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 | MODEL 1192 SCS ANCHORS (X 2) |
Patient Outcome(s) |
Other;
|
Patient Age | 38 YR |