Brand Name | SPECTRA WAVEWRITER |
Type of Device | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Manufacturer (Section D) |
BOSTON SCIENTIFIC NEUROMODULATION |
25155 rye canyon loop |
valencia CA 91355 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
cashel road |
|
clonmel |
EI
|
|
Manufacturer Contact |
talar
tahmasian
|
25155 rye canyon loop |
valencia, CA 91355
|
6619494863
|
|
MDR Report Key | 15611517 |
MDR Text Key | 301811873 |
Report Number | 3006630150-2022-05551 |
Device Sequence Number | 1 |
Product Code |
LGW
|
UDI-Device Identifier | 08714729951254 |
UDI-Public | 08714729951254 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030017 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Remedial Action |
Modification/Adjustment |
Type of Report
| Initial |
Report Date |
10/14/2022 |
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 Expiration Date | 07/08/2021 |
Device Model Number | SC-1160 |
Device Catalogue Number | SC-1160 |
Device Lot Number | 357529 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/23/2022 |
Initial Date FDA Received | 10/14/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/10/2019 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 74 YR |
Patient Sex | Male |