Manufacturer (Section D) |
BOSTON SCIENTIFIC NEUROMODULATION |
25155 rye canyon loop |
valencia CA 91355 |
|
Manufacturer Contact |
talar
tahmasian
|
25155 rye canyon loop |
, |
valencia, CA 91355
|
6619494863
|
|
MDR Report Key | 8862239 |
MDR Text Key | 153343413 |
Report Number | 3006630150-2019-04043 |
Device Sequence Number | 1 |
Product Code |
NHL
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P150031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/05/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/16/2019
|
Initial Date FDA Received | 08/05/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Death;
Other;
|
|
|