Brand Name | REVO MRI SURESCAN |
Type of Device | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
Manufacturer (Section D) |
MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer (Section G) |
MEDTRONIC MED REL MEDTRONIC PUERTO RICO |
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 | 12279581 |
MDR Text Key | 265144299 |
Report Number | 3004209178-2021-11939 |
Device Sequence Number | 1 |
Product Code |
LWP
|
UDI-Device Identifier | 00613994614742 |
UDI-Public | 00613994614742 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P090013 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/05/2021 |
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 |
Lay User/Patient
|
Device Expiration Date | 08/28/2013 |
Device Model Number | RVDR01 |
Device Catalogue Number | RVDR01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/14/2021 |
Initial Date FDA Received | 08/05/2021 |
Date Device Manufactured | 03/12/2012 |
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 | 5086MRI45 LEAD, 5086MRI52 LEAD |
Patient Age | 80 YR |
Patient Weight | 101 |
|
|