Brand Name | PRECISION |
Type of Device | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Manufacturer (Section D) |
BOSTON SCIENTIFIC NEUROMODULATION |
25155 rye canyon loop |
valencia CA 91355 |
|
MDR Report Key | 11320922 |
MDR Text Key | 231576425 |
Report Number | 3006630150-2021-00447 |
Device Sequence Number | 1 |
Product Code |
LGW
|
Combination Product (y/n) | N |
PMA/PMN Number | P030017 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
04/02/2021 |
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? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | SC-5312 |
Device Catalogue Number | SC-5312 |
Device Lot Number | 377804 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/21/2021 |
Initial Date FDA Received | 02/12/2021 |
Supplement Dates Manufacturer Received | 03/10/2021
|
Supplement Dates FDA Received | 04/02/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 66 YR |
|
|