Brand Name | OCTRODE TRIAL LEAD KIT, 60CM LENGTH |
Type of Device | SCS TRIAL 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 |
melissa
nkematu
|
6901 preston road |
plano, TX 75024
|
9723092520
|
|
MDR Report Key | 7871801 |
MDR Text Key | 120097270 |
Report Number | 3006705815-2018-02264 |
Device Sequence Number | 1 |
Product Code |
GZB
|
UDI-Device Identifier | 05414734401555 |
UDI-Public | 05414734401555 |
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,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/12/2018 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/02/2020 |
Device Model Number | 3086 |
Device Lot Number | A000060965 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/19/2018
|
Initial Date FDA Received | 09/13/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/03/2018 |
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(2), SCS ANCHOR; MODEL 3189(2), SCS LEAD; MODEL 3660, SCS IPG |
Patient Outcome(s) |
Other;
|
Patient Age | 46 YR |