Brand Name | SURESCAN |
Type of Device | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR |
Manufacturer (Section D) |
MPRI |
road 149 km 56.3 |
villalba PR 00766 |
|
Manufacturer (Section G) |
MPRI |
road 149 km 56.3 |
|
villalba PR 00766 |
|
Manufacturer Contact |
david
gustafson
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635149628
|
|
MDR Report Key | 11970287 |
MDR Text Key | 255373578 |
Report Number | 2649622-2021-11525 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 00763000006570 |
UDI-Public | 00763000006570 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/09/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 977D260 |
Device Catalogue Number | 977D260 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/19/2021 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/08/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/11/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |