Brand Name | INTERSTIM |
Type of Device | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON |
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 |
glen
belmer
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
6122713209
|
|
MDR Report Key | 19033681 |
MDR Text Key | 339262192 |
Report Number | 3004209178-2024-08378 |
Device Sequence Number | 1 |
Product Code |
EZW
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P970004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/03/2024 |
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 | 11/28/2022 |
Device Model Number | 97810 |
Device Catalogue Number | 97810 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/02/2024
|
Initial Date FDA Received | 04/03/2024 |
Date Device Manufactured | 06/08/2021 |
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 Age | 21 YR |
Patient Sex | Female |
Patient Weight | 82 KG |
|
|