Brand Name | PROCLAIM 7 ELITE |
Type of Device | SCS IPG |
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 | 8753097 |
MDR Text Key | 149788567 |
Report Number | 1627487-2019-07641 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 05415067020222 |
UDI-Public | 05415067020222 |
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 |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
04/02/2020 |
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 | 11/25/2017 |
Device Model Number | 3662 |
Device Catalogue Number | 3662 |
Device Lot Number | 5304011 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/13/2019 |
Initial Date FDA Received | 07/02/2019 |
Supplement Dates Manufacturer Received | 08/27/2019 01/07/2020 01/24/2020 03/30/2020
|
Supplement Dates FDA Received | 08/28/2019 01/24/2020 01/27/2020 04/02/2020
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/25/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 1627487/06/02/2017/001-C |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Weight | 73 |