Brand Name | ADVISA MRI SURESCAN |
Type of Device | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
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 |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 14683722 |
MDR Text Key | 293911320 |
Report Number | 3004209178-2022-07551 |
Device Sequence Number | 1 |
Product Code |
NVZ
|
UDI-Device Identifier | 00643169493377 |
UDI-Public | 00643169493377 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P980035 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/14/2022 |
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 |
Lay User/Patient
|
Device Expiration Date | 07/28/2018 |
Device Model Number | A2DR01 |
Device Catalogue Number | A2DR01 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/20/2022 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/18/2022 |
Initial Date FDA Received | 06/14/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/09/2017 |
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 |
Treatment | 5076-52 LEAD, 5076-58 LEAD |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 74 YR |
Patient Sex | Female |