Brand Name | PROTÉGÉ MRI IPG |
Type of Device | SCS IPG |
Manufacturer (Section D) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) |
lot a interior - #2 street km 67.5 |
santana industrial park |
arecibo PR 00612 |
|
Manufacturer Contact |
martha
livingston
|
plano, TX 75024
|
9725264871
|
|
MDR Report Key | 7068310 |
MDR Text Key | 93244074 |
Report Number | 3006705815-2017-07168 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/29/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/29/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2017 |
Device Model Number | 3771 |
Device Lot Number | 5131860 |
Other Device ID Number | 05415067017086 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/08/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/22/2015 |
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 | MODEL 3228 SCS LEAD |
Patient Outcome(s) |
Other;
|
Patient Age | 35 YR |
Patient Weight | 104 |
|
|