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 00777 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer Contact |
lisa
woodward clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 7664871 |
MDR Text Key | 113262822 |
Report Number | 3004209178-2018-15101 |
Device Sequence Number | 1 |
Product Code |
MHY
|
UDI-Device Identifier | 00613994934604 |
UDI-Public | 00613994934604 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P960009 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/05/2018 |
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 | 09/14/2015 |
Device Model Number | 37601 |
Device Catalogue Number | 37601 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/02/2018 |
Initial Date FDA Received | 07/05/2018 |
Date Device Manufactured | 03/26/2014 |
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) |
Other;
|
Patient Age | 73 YR |
|
|