Brand Name | ACTIVA |
Type of Device | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos,pr MN 00777 1200 |
|
MDR Report Key | 9087952 |
MDR Text Key | 159316789 |
Report Number | 3007566237-2019-01994 |
Device Sequence Number | 1 |
Product Code |
MHY
|
Combination Product (y/n) | N |
PMA/PMN Number | P960009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
11/08/2019 |
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 Expiration Date | 04/14/2019 |
Device Model Number | 37601 |
Device Catalogue Number | 37601 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/16/2019 |
Initial Date FDA Received | 09/19/2019 |
Supplement Dates Manufacturer Received | 10/21/2019
|
Supplement Dates FDA Received | 11/08/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 32 YR |
|
|