Brand Name | GENESIS PATIENT PROGRAMMER |
Manufacturer (Section D) |
ST. JUDE MEDICAL- NEUROMODULATION |
6901 preston rd. |
plano TX 75024 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL- NEUROMODULATION |
6901 preston rd. |
|
plano TX 75024 |
|
Manufacturer Contact |
connie
timmons
|
6901 preston rd. |
plano, TX 75024
|
9723098054
|
|
MDR Report Key | 3683134 |
MDR Text Key | 20697690 |
Report Number | 1627487-2014-12039 |
Device Sequence Number | 1 |
Product Code |
GZB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
12/19/2013 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/15/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/01/2013 |
Device Model Number | 3850 |
Device Lot Number | 3454956 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/19/2013 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/01/2011 |
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 |
Treatment | IMPLANT DATE:; SCS LEAD: MODEL 3186; SCS IPG: MODEL 3609; IMPLANT DATE: |
Patient Outcome(s) |
Other;
|
Patient Age | 66 YR |