Brand Name | ALLURE RF |
Type of Device | IMPLANTABLE PACEMAKER PULSE GENERATOR |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
denise
johnson
|
5050 nathan lane north |
plymouth, MN 55442
|
6517564470
|
|
MDR Report Key | 6703913 |
MDR Text Key | 79744866 |
Report Number | 2017865-2017-06334 |
Device Sequence Number | 1 |
Product Code |
NKE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970013 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/17/2017 |
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 |
Health Professional
|
Device Expiration Date | 11/30/2017 |
Device Model Number | PM3222 |
Device Lot Number | A000023342 |
Other Device ID Number | 05414734507905 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/07/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/14/2017 |
Initial Date FDA Received | 07/11/2017 |
Supplement Dates Manufacturer Received | 08/01/2017 10/05/2017
|
Supplement Dates FDA Received | 08/02/2017 10/17/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/25/2016 |
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 |