Brand Name | PROCLAIM¿ 7 IPG |
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 |
|
MDR Report Key | 7498456 |
MDR Text Key | 107726196 |
Report Number | 1627487-2018-04279 |
Device Sequence Number | 1 |
Product Code |
LGW
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial,Followup,Followup |
Report Date |
07/16/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/09/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/05/2019 |
Device Model Number | 3667 |
Device Lot Number | 6046526 |
Other Device ID Number | 05415067023254 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/06/2018 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 07/10/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/05/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 1627487-060217-001-C |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|