Brand Name | 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B |
Type of Device | DBS LEAD |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION |
6901 preston rd |
plano TX 75024 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION |
6901 preston rd |
|
plano TX 75024 |
|
Manufacturer Contact |
andrea
deitz
|
6901 preston road |
plano, TX 75024
|
9723098000
|
|
MDR Report Key | 8069142 |
MDR Text Key | 127092191 |
Report Number | 1627487-2018-12023 |
Device Sequence Number | 1 |
Product Code |
MHY
|
UDI-Device Identifier | 05415067020635 |
UDI-Public | 05415067020635 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | P140009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
12/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/15/2020 |
Device Model Number | 6170 |
Device Catalogue Number | 6170 |
Device Lot Number | 6320021 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/22/2018 |
Initial Date FDA Received | 11/14/2018 |
Supplement Dates Manufacturer Received | 12/17/2019
|
Supplement Dates FDA Received | 12/19/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/15/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 1627487-10/16/18-001-R |
Patient Sequence Number | 1 |
|
|