Brand Name | SYNERGY |
Type of Device | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
Manufacturer (Section D) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
humacao PR 00792 |
|
Manufacturer (Section G) |
MDT SOFAMOR DANEK PUERTO RICO MFG |
barrio marianna rd 909, km0.4 |
|
humacao PR 00792 |
|
Manufacturer Contact |
lisa
clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 6247373 |
MDR Text Key | 64674058 |
Report Number | 1030489-2017-00083 |
Device Sequence Number | 1 |
Product Code |
LGW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P840001 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/12/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/14/2002 |
Device Model Number | 7427 |
Device Catalogue Number | 7427 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/09/2017 |
Date Device Manufactured | 08/26/2000 |
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) |
Life Threatening;
Required Intervention;
|
Patient Age | 39 YR |
|
|