Brand Name | OCTRODE LEAD KIT, 60CM LENGTH |
Type of Device | PERCUTANEOUS 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 |
|
MDR Report Key | 12388191 |
MDR Text Key | 268888858 |
Report Number | 3006705815-2021-04274 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067017246 |
UDI-Public | 05415067017246 |
Combination Product (y/n) | N |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
09/15/2021 |
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 | 03/06/2021 |
Device Model Number | 3186 |
Device Catalogue Number | 3186 |
Device Lot Number | A000076057 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/12/2021 |
Initial Date FDA Received | 08/30/2021 |
Supplement Dates Manufacturer Received | 09/09/2021
|
Supplement Dates FDA Received | 09/15/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | PERCUTANEOUS LEAD |
Patient Outcome(s) |
Other;
|
Patient Weight | 104 |
|
|