Brand Name | NEURX DIAGPHRAGM PACING SYSTEM |
Type of Device | DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR |
Manufacturer (Section D) |
SYNAPSE BIOMEDICAL INC. |
300 artino street |
oberlin OH 44074 |
|
Manufacturer Contact |
mark
barbutes
|
300 artino street |
oberlin, OH 44074
|
4407742488
|
|
MDR Report Key | 5266874 |
MDR Text Key | 32748621 |
Report Number | 3005868392-2015-00002 |
Device Sequence Number | 1 |
Product Code |
OIR
|
UDI-Device Identifier | 00852184003281 |
UDI-Public | (01)00852184003281 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | H100006 |
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 |
10/26/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/01/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 07/31/2013 |
Device Model Number | 20-0045 |
Device Lot Number | 20-0045-100212-10-1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/18/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/02/2012 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 51 YR |