Brand Name | PERCEPTA 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 | 8531829 |
MDR Text Key | 142499308 |
Report Number | 3004209178-2019-07848 |
Device Sequence Number | 1 |
Product Code |
NKE
|
UDI-Device Identifier | 00643169735644 |
UDI-Public | 00643169735644 |
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 |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/03/2019 |
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 |
Lay User/Patient
|
Device Expiration Date | 07/14/2020 |
Device Model Number | W4TR01 |
Device Catalogue Number | W4TR01 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/22/2019 |
Initial Date FDA Received | 04/19/2019 |
Supplement Dates Manufacturer Received | 05/15/2019
|
Supplement Dates FDA Received | 06/03/2019
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/17/2019 |
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 | 429888 LEAD, 5076-52 LEAD, 5076-58 LEAD |
Patient Age | 80 YR |
|
|