Brand Name | ACTIVA |
Type of Device | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
Manufacturer (Section D) |
MPRI |
road 149 km 56.3 |
villalba PR 00766 |
|
Manufacturer (Section G) |
MPRI |
road 149 km 56.3 |
|
villalba PR 00766 |
|
Manufacturer Contact |
lisa
woodward clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 8372067 |
MDR Text Key | 137247862 |
Report Number | 2649622-2019-03172 |
Device Sequence Number | 1 |
Product Code |
MHY
|
UDI-Device Identifier | 00643169752276 |
UDI-Public | 00643169752276 |
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 |
company representative,health |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial,Followup |
Report Date |
02/26/2019 |
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 | 07/16/2021 |
Device Model Number | 3389S-40 |
Device Catalogue Number | 3389S-40 |
Device Lot Number | VA1VCX8 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/22/2019 |
Initial Date FDA Received | 02/26/2019 |
Supplement Dates Manufacturer Received | 02/22/2019
|
Supplement Dates FDA Received | 02/26/2019
|
Date Device Manufactured | 10/09/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-1190-2013 |
Patient Sequence Number | 1 |
Patient Age | 60 YR |
Patient Weight | 78 |
|
|