Type of Device | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
Manufacturer (Section D) |
MEDTRONIC NEUROMODULATION |
800 53rd ave ne |
minneapolis MN 55421 1200 |
|
Manufacturer (Section G) |
MEDTRONIC NEUROMODULATION |
800 53rd ave ne |
|
minneapolis MN 55421 1200 |
|
Manufacturer Contact |
lisa
woodward clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 7717802 |
MDR Text Key | 115391936 |
Report Number | 3007566237-2018-02203 |
Device Sequence Number | 1 |
Product Code |
LKK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P860004 |
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,Followup |
Report Date |
10/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | NEU_UNKNOWN_PUMP |
Device Catalogue Number | NEU_UNKNOWN_PUMP |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/16/2018 |
Initial Date FDA Received | 07/25/2018 |
Supplement Dates Manufacturer Received | 08/08/2018
|
Supplement Dates FDA Received | 10/03/2018
|
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 |
|
|