Brand Name | PROCLAIM¿ |
Type of Device | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
6901 preston rd |
plano, tx TX 75024 |
|
MDR Report Key | 7747193 |
MDR Text Key | 115935788 |
Report Number | 7747193 |
Device Sequence Number | 1 |
Product Code |
LGW
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/05/2018,03/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/03/2018 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 7 ELITE |
Device Catalogue Number | 3662 |
Device Lot Number | 5791866 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/19/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/05/2018 |
Device Age | 1 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/03/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 28105 DA |
Patient Weight | 63 |
|
|