Brand Name | ACTIVA |
Type of Device | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
Manufacturer (Section D) |
IPG MFG SWITZERLAND |
route du molliau 31 |
tolochenaz 1131 |
CH 1131 |
|
Manufacturer (Section G) |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne rcw215 |
|
minneapolis MN 55432 |
|
Manufacturer Contact |
diane
wolf
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263987
|
|
MDR Report Key | 3640480 |
MDR Text Key | 4285021 |
Report Number | 9614453-2014-00423 |
Device Sequence Number | 1 |
Product Code |
MRU
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | H020007 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/29/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/28/2014 |
Device Model Number | 37601 |
Device Catalogue Number | 37601 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/29/2014 |
Initial Date FDA Received | 02/21/2014 |
Date Device Manufactured | 10/01/2012 |
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) |
Required Intervention;
|
|
|