Brand Name | SERENA QUAD CRT-P MRI SURESCAN |
Type of Device | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
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 | 9616770 |
MDR Text Key | 175912307 |
Report Number | 3004209178-2020-01562 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00643169735668 |
UDI-Public | 00643169735668 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010015 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
01/22/2020 |
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 | 07/28/2020 |
Device Model Number | W4TR02 |
Device Catalogue Number | W4TR02 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/23/2019 |
Initial Date FDA Received | 01/22/2020 |
Date Device Manufactured | 02/13/2019 |
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 | 407652 LEAD, 407645 LEAD, 1458QL-75 LEAD |
Patient Age | 85 YR |
|
|